Offer strategic advice and insights to help the organization achieve its mission and goals.Provide input on long-term planning and vision. Provide industry knowledge and experience to guide the organization in navigating challenges and opportunities. Stay informed about industry trends and best practices. Help identify potential risks and challenges facing the organization. Provide advice on risk mitigation strategies. Serve as a mentor to key members of the organization, including executives and staff. Offer guidance and support based on their own professional experiences.

As a Subject matter Expert for FDA and QA/Regulatory compliance, I have been responsible for collaborating on all compliance initiatives associated with applicable FDA, ISO, Information Security, Privacy, and SOX regulatory compliance issues. I have managed QA projects related to the global upgrade of ERP implementations. Executed strategies for maintaining compliance with IT management, Internal Audit, and Corporate Regulatory. System Administrator for Internal IT Audit and 21 CFR Part 11 Data Management Base systems. Responsibility and management of improvement for company-wide Quality System and regulatory affairs for biomedical devices and pharmaceutical companies. As an active member of the leadership team, I have hosted, Interfaced, supported, and defended the organization directly with internal and external regulatory auditors (FDA, ISO, Health Canada, and EU approvals).

Responsible for performing engineering design evaluations, continuous improvement, and maintaining the quality management system, working to complete cost savings projects within budget and scheduling restraints for Medical Imaging Equipment. Provide guidance for industry policies and procedures to ensure compliance with applicable regulatory standards, such as FDA regulations cGMP 21 CFR 820, ISO 13485, ISO 14971, ISO 9001, EN 46001, UL Listing, and other relevant regulatory requirements. Review reports of production, malfunction, and maintenance to determine or address problems. Provide technical support for the engineering process.·        Establish and enforce quality assurance processes throughout the product lifecycle, including design control, manufacturing, and post-market surveillance. Perform risk assessments to reduce risk and optimize timelines.·        Accountable for product development and improvement of new and existing products. ·        Review and approve validation protocols, test methods, and product specifications to ensure compliance with quality standards. Responsible for vendor tech transfers of PCB boards.·        Responsible for achieving $1.5 million rework components recovery for PCB boards and reducing product cost by 50%.·        Manage project budget to stay within cost guidelines for the product.

Responsible for initiating, reviewing, and approving Post Market investigations for deviations, non-conformances, and complaints for aseptic/sterile manufacturing for Cell/Gene Therapy products of Janssen. Ensure the quality assurance of all internal and CMOs sites working with Janssen to conform to the pharmaceutical quality standards and the regulatory authorities (FDA & EMA). Approved Batch release.• Review solution/formulation prep, terminal sterilization, aseptic fill, clean room, isolator fill, automated inspection, lab scale equipment, and finishing/packaging processes.• Review manufacturing, analytical, and supply chain deviations and investigations.• Review OOS/OOT investigations. Utilized MS Teams, MS Office, and TrackWise.• Reviewed incidents for appropriate and timely investigation handling, corrective, and preventive action. Participated in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor.

Worked closely with Vaccitech Staff to advise and oversee GCP and GMP compliance in the Clinical, Laboratory, and Manufacturing groups in accordance with local and international quality requirements. Review and approve key quality documents, including SOPs, Policies, Forms, batch documentation, validation/qualification documentation, and Quality Agreements.• Provided quality management support for the implementation of the Pre and Post Market/R&D Quality Management System (QMS), including SOPs, Deviations, CAPA, Change Control, Audits, risk management, and vendor management. • Ensuring good practices (GxP) are communicated, adopted, and implemented throughout the organization by maintaining current knowledge of local and international regulations;• Providing Quality expertise and oversight internally to project teams and other departments• Performing internal, CSP, clinical site, CDMO, and study-specific audits. Supporting the risk-based annual External/Contract Service Provider (CSP) audit program and maintaining the Approved Supplier List and internal audit program by creating an annual internal audit schedule.• Supported selection and implementation of a global electronic Quality Management System (eQMS).

Provided Quality cGMP oversight in a Supply Chain capacity for the entire CMC manufacturing process of Bulk Drug Solution/API to finishing of a sterile fill/aseptic pharmaceutical manufacturer for Injectable Vaccine Products for the CMO site.• Responsible for assuring the quality of materials received by AstraZeneca from the designated supplier portfolio and will proactively ensure GMP and regulatory compliance during supplier-related projects. Drive quality improvements at the supplier as part of a cross-functional team.• Responsible for the Quality System oversight of supplier-related product quality complaints, change controls, deviation investigations, issue management and escalation, and Quality Agreements between AstraZeneca and External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments and support to Regulatory Agency inspections of supplier sites and site transfers.• Provided oversight and guidance to the Site Quality/Manufacturing Operations, functions including but not limited to documentation, deviation, CAPA, and Change Control. Utilized MS Teams, MS Office, TrackWise, and Veeva eQMS.

Oversaw the generation and review of documents used in GMP activities such as quality agreements, COAs, analytical validations/transfers, process validations, master and executed batch records, label proofs, specifications, and change controls. Provide CMC experience as a QA liaison, tablet manufacturing, CDMOs, and a GMP lead auditor.• Develop a comprehensive program plan outlining the goals, objectives, and timelines for implementing the eQMS. Define key milestones and deliverables to ensure the program progresses effectively. Establish a communication plan to keep stakeholders informed about the program's status and achievements.• Establish metrics and key performance indicators (KPIs) to measure the success of the eQMS program. Regularly evaluate the program's performance and make adjustments as necessary to achieve objectives.• Executed batch record review and batch disposition of Drug substances, Drug products, and Finished Products. Quality review of stability analytical data and reports.• Review of executed clinical labeling batch records and labeled lot disposition to US and EU• Review/approve clinical labels for use in the US and EU. Tracked quality metrics/trending data of compliance issues for Phase I, II, and III clinical trial studies.• Contribute to vendor management program by evaluating questionnaires, audit reports, and risk assessment documents for manufacturers, analytical laboratories, and other vendors.• Review and approve manufacturing, analytical, and supply chain deviations and investigations prior to lot disposition. Review OOS/OOT investigations. Performed external audits and participated in the evaluation/selection of CMO/CROs and other clinical and non-clinical service providers.

Provided cGMP oversight in a Technical Operations capacity for the entire CMC manufacturing process of Bulk Drug Solution/API to finishing of a sterile fill/aseptic pharmaceutical manufacturer for Injectable Vaccine Products at the CMO site.• Monitored solution/formulation prep, terminal sterilization, aseptic fill, isolator fill, automated inspection, and finishing/packaging processes. • Overseen sterile fill for bottle/vial finished product manufacturing, batch record review, environmental monitoring, facilities maintenance, materials handling, and validation per regulatory and site requirements.• Responsible for Batch Records review and product release. Reviewed data and significant deviations identified in batch records and submitted a summary of findings with management recommendations.• Reviewed incidents for appropriate and timely investigation handling, corrective, and preventive action. Participated in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor. Responsible for training/mentoring full-time staff on cGMP and Aseptic techniques.

Responsible for leading investigations related to Biologics Manufacturing (i.e., Upstream and Downstream) to support clinical/commercial Biotechnology Products. Work with manufacturing and QA teams to agree on appropriate CAPAs as needed. In addition, review, revise or create Standard Operating Procedures, Validation Protocols, and Risk Assessments: utilized MS Teams, MS Office, and Veeva eQMS.• Lead significant and critical deviations related to biologics Manufacturing or Laboratory Testing to support clinical and commercial biotechnology products.• Subject Matter Expert in Quality and Compliance in the biopharmaceutical industry.• Coordinated and follow-up with personnel/department managers where the event occurred to gather additional information, facts, documents, and applicable data for deviations and CAPAs.• Utilized root cause analysis techniques during the deviation investigation process and performed a prompt and thorough investigation to comply with associated regulatory requirements.• Created, reviewed, and approved appropriate policies, directives, and procedures aligned with relevant governmental regulations and guidelines.• Provided active participation during regulatory agency inspections, as needed. Assist Quality Compliance management in maintaining a state of inspection readiness and compliance.

Responsible for conducting complaint investigations, including intake, reportability assessment, investigation, and closure. Proactively involved cross-functional team members during investigations including, but not limited to, members from R&D, Manufacturing, Technical support, Logistics, Field Service Engineers, and CMOs to determine root cause and corrective actions as needed.• Participating in Product Care and/or CAPA meetings and providing support as needed• Detailed complete and accurate findings regarding each complaint investigation, including the conclusion and any corrective actions taken• Maintain the complaint and SCAR records as required by regulations• Communicating findings to technical services and management in concise summary formats• Participating and supporting the analysis, tracking, and trending of complaints data on a weekly and monthly basis for Technical and QA meetings• Participate and provide vital records and support for internal or external audits• Collaborating with co-workers to meet business objectives and improve team capability• Working on other quality department assignments with broadly defined goals as assigned• Solve non-routine issues, challenges, and problems within the field of specialization• Perform supplier corrective action reports with CMOs. Utilized MS Teams, MS Office, and Veeva eQMS.

Responsible for conducting and writing investigations for deviations, non-conformances, and complaints for aseptic/sterile manufacturing for Biologic vaccines products within this pharmaceutical company. Ensure products are in compliance with FDA and other health authority regulations and/or customer specifications for product release.• Review deviations that impact the product quality and the associated CAPA to ensure that mitigations are appropriate and effective.• Track and report on plant quality Key Performance Indicators. Train and direct QA Operations Teams within CMC.• Determined that products meet FDA commitments and/or customer specifications and approve products for release to customers. • Provided oversight and guidance to the Site Quality/Manufacturing• Operations, functions including but not limited to documentation, deviation, CAPA, and Change Control.

Responsible for conducting and writing investigations for deviations, incidents, quality issues, and complaints for aseptic/sterile manufacturing for Biologic products within this CMO pharmaceutical company. Document findings, perform trend analysis, and communicate to management, employees, and customers as appropriate. Ensured corrective actions and follow-up reports were tracked and completed. Includes physical inspection of equipment, buildings, and facility grounds for internal, regulatory, or customer audits. Performed Root Cause Analysis and determine and wrote CAPA Plans. ● Determined that products meet FDA commitments and/or customer specifications, and approve products for release to customers. Track and report on plant quality Key Performance Indicators. ● Train and direct QA operations at several levels. Participate in Quality and Operations Teams within CMC.

Responsible for conducting and writing investigations for deviations, incidents, quality issues, and complaints for aseptic/sterile manufacturing for CMC products within this pharmaceutical company. Document findings, performed trend analysis, and communicated to management, employees and customers as appropriate. Ensured corrective actions and follow-up reports were tracked and completed. Includes physical inspection of equipment, buildings, and facility grounds for internal, regulatory, or customer audits. Performed Root Cause Analysis and determine and wrote CAPA Plans. ● Determined that products meet FDA commitments and/or customer specifications, and approve products for release to customers. Track and report on plant quality Key Performance Indicators. Yellow Belt Certified by Pfizer. ● Train and direct QA operations at several levels. Participate on Quality and Operations Teams within CMC.

- Responsible for overseeing Pre/Post market product complaints and CAPA/SCAR for both drug and combination products within this biotechnology company. Performing investigations related to product complaints and non-conforming events to ensure compliance with the FDA and other worldwide health authority CGMP regulations and guidelines, site SOPs, and industry standards. Provide recommendations for corrective and preventative action to the Quality Senior Management team. Lead Non-conformance Monitoring team.• Lead and develop the group responsible for handling Pre and Post Market Product Quality Surveillance and CAPAs. • Review product complaints received for Acorda products. Identify product complaints that meet field alert or recall reporting requirements and coordinate management reviews by the Heads of Quality, Regulatory, Technical Operations, the Head of Drug Safety, Risk Management, Clinical Development, and Medical Affairs, as appropriate. Develop Risk and Compliance strategies for cGMP Quality.• Performed investigations for consumer product complaints and wrote deviations and non-conformances for manufacturing.• Track quality metrics/KPI's of compliance issues and their resolution. Implementing a QMS system for Complaints and CAPA.• Present product complaint information or non-conforming events, independently, to in-house client staff and, if appropriate, to the responsible individuals at service providers. Performed a Gap Analysis and remediation to improve cGMP processes and procedures.• Act as a key point of contact for compliance-related activities of QMS inspections (FDA, Internal/External Audits)

Overseen the development and deployment of Quality Management Systems (QMS) at this Global Chemicals location. Ensured the transition of the business unit’s Quality Management System and manufacturing operations from ISO 9001:2008 to being certified to ISO13485 and GMP compliance. Performed verification of documented systems that comply with the requirements of all regulatory standards and agency authorities to which Global Chemicals is accountable. • Performed 21 CFR 820 and ISO 13485 internal GAP assessment for cGMP compliance and ISO Certification.• Responsible for all Regulatory Affairs activities including promotional review of marketing materials and product labeling to FDA and USP requirements for the U.S. and E.U. Provided regulatory oversight and advice regarding advertising and promotional materials. • Experienced with QA/QC, RA, material handling, and safety of chemicals for packaging and distribution of bottles, barrels, and railroad tankers shipments and deliveries. Provided compliance support for various product and process-related activities.• Provided regulatory interface during the product commercialization process and throughout the entire product life cycle including post-market surveillance. Developed remediation plans to meet FDA and ISO requirements.• Interacted with sourcing leaders as required to establish the expected supplier performance management qualifications.• Collaborated with supplier quality engineering to develop methods for supplier certification. Managed all documentation Control.• Responsible for adherence to all applicable standards related to FDA registered medical devices and USP Compendia products.

Ensured project requirements and business processes were identified and documented, and methodology deliverable timelines were met. Utilized Quality by Design for the development processing of their products for this new facility. Organized, scheduled, and managed infrastructure, production, and lab (LIMS) equipment validation activities with a cross-functional team. This position’s other responsibilities include protocol generation, Agile project management tools, protocol execution, and final summary report. Ensured project requirements and business processes were identified, documented, and deliverable methodology timelines were met—utilized Quality by Design to develop their products for this new facility.• Program manager of staff and equipment validation activities related to Novo Nordisk biologic/small-molecule Drug Substance and Drug Products, specifically in the aseptic and formulation environment. Review the CAPA Management process to streamline closures.• Develop a comprehensive program plan outlining the goals, objectives, and timelines for implementing the eQMS. Define key milestones and deliverables to ensure the program progresses effectively. Establish a communication plan to keep stakeholders informed about the program's status and achievements.• Led and represented validation in multi-departmental meetings and project teams to identify and implement improvements to the QA Equipment Validation systems (department-level impact). Determined QA metrics on validation deviations and non-conformance.• Provided regulatory guidance for Manufacturing, Change Control, Process Development, and QMS system. Utilized MS Project and Agile/Waterfall methodologies.• Reviewed IQ, OQ, and PQ protocols for accuracy and content.• Sterile Manufacturing

Conducted complex technical audits and SOX controls testing, including data security and access control; business and disaster recovery; program change management; internal and external networks and communications; and physical security. •Performed information technology audits, application control reviews and Sarbanes-Oxley (SOX) controls testing.•Prepared audit programs, conducted risk evaluations, devised/performed tests of controls, prepared audit reports of findings, and related recommendations.•Verified efficiency and effectiveness of operation, reliability of information, and compliance with applicable laws and regulations.•Recommended control improvements, communicated findings, and recommendations to management •Documented audit work using automated audit management tools and follow up on the status of corrective actions.

Demonstrate working experience in a QA capacity in a sterile fill / aseptic process pharma - manufacturing environment. Monitoring manufacturing processes, assuring documentation requirements are met, and initiating appropriate investigation activities and related documentation when manufacturing deviations occur.•Oversee sterile fill for bottle and syringe finished product manufacturing, batch record review, facilities maintenance, materials handling, validation in accordance with mandated regulatory requirements, and site expectations.•Participate in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor.•Review complaints for appropriate investigation handling.•Responsible to train/mentor full-time staff.

Processing and remediation of customer complaints for Class II and III Medical Devices (Implantable spinal devices) plus maintenance of complaint files, responses to customers, and Quality reports. This includes evaluating/performing investigations, CAPA, OOS, Non-conformances, Medical Device Reports, Field Actions, and supporting product platform teams.• Implement and follow procedures to ensure timely and accurate receipt, analysis, and response to customer complaints. Reviews all Customer complaints for validity and assures complaints are processed in compliance with Division policies and procedures.• Maintain systems to monitor and facilitate timely investigations and closeout of open complaints. Ensure systems at workflow preclude lengthy unanswered complaints. Contribute to the business-wide quality strategy and quality objectives.• Monitor and communicate significant-quality trends and identify adequate corrective/preventive actions and remediation requirements.• Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, Medical Device Directives, and Vigilance.

Demonstrate working experience in a QA capacity in a sterile fill / aseptic process pharma - manufacturing environment. Monitoring manufacturing processes, assuring documentation requirements are met, and initiating appropriate investigation activities and related documentation when manufacturing deviations occur.•Oversee sterile fill for bottle and syringe finished product manufacturing, batch record review, facilities maintenance, materials handling, validation in accordance with mandated regulatory requirements, and site expectations.•Participate in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor.•Review complaints for appropriate investigation handling.•Responsible to train/mentor full-time staff.

Oversee and facilitate Quality Systems development of OTC Drug, Cosmetic, Medical Device manufacturing facilities for existing and new products. Work with and lead global marketing teams to prepare for the execution of platform strategies and product launches.• Provide advice and counsel to staff and global manufacturing facilities regarding compliance with state, FDA Quality System, and GMP requirements as well as international standards when necessary.• Monitor quality activity to ensure seamless integration with processes and cross-functional teams R&D, RA, and P&TD• Assist in regulatory resolution and/or quality issues and recommend corrective actions.• Integrate and coordinate activities within clearly defined policies and develop and champion quality/regulatory policies for vendors and suppliers.

Work with Owners of nonconformity events to investigate and document the nonconformity in the Exception Report (ER) system. Ensure that ER investigations are thorough, complete and, through the use of investigative tools, determines the root cause of the nonconformity. Work closely with functional areas to ensure that CAPA plans address root causes and are processed through the quality system efficiently. • Provide ongoing support on the use of the CAPA system and investigation process. Work with the users of the CAPA to ensure that the CAPA system operates effectively and complies with regulatory and corporate requirements.• Evaluate exception reports and make investigative recommendations to ensure that the reports are consistent with respect to the CAPA process. Create and edit documents within the ER system to ensure that ERs are clearly and concisely documented.• Facilitate the ER investigation process to ensure that the CAPA process is timely, identifies the appropriate root cause, and implements effective actions to reduce the occurrence/reoccurrence of the non-conformance.• Provide ongoing support to CAPA system users on the CAPA process, problem-solving, and system software access.• Ensure that the CAPA system is “audit ready” for internal and external quality system audits

Managed improvements to ensure that the action implemented meets the required specification. Document risk and root cause analysis corrective/preventive actions taken. Monitor interval and criteria to verify CAPA effectiveness.• Provide rigorous assessment of CAPA activities and documentation to assure compliance with CAPA policies and procedures, ITIL, FDA regulations, and ISO 13485 through the review of CAPA records at critical phases. • Effective analysis of non-conformance trends (lead Non-conformance Monitoring team)• Responsible for managing the execution of the CAPA management process and deploying a uniform approach of corrective and preventive actions. Expedite closures of non-active nonconforming incidents and CAPAs.• Generate, communicate, and track metrics relating to non-conforming incidents and CAPA Management. • Identify and act on any CAPA escalations requiring further attention and discussions with business owners.

Facilitate ECN, NCR, CAPA process, and activities. Monitor, analyze data, and trending for Complaint Handling documentation. Support activities for process improvements and systems integration projects.* Review ECN, NCR, and CAPA status for accuracies and verify closure.* Perform trend analysis and identify negative trends to target for improvement* Utilize NetRegulus to review PER, NCR, and CAPA related activities. * Ensure compliance with the Divisional CAPA process requirements across all plants.* Maintain divisional metrics. Communicate CAPA data and information to management.* Provide information, as appropriate, to feed into the corporate CAPA process. Support Stryker Orthopaedics' continuous improvement initiatives. Perform and participate in divisional training on systems and/or processes related to Complaint Handling.

With this Clinical Research Organization, I participated in Information Security, Quality and Validation processes and activities supporting the IS Department, and provided regulatory support for clinical submissions.• Prep. Of CMC-related submissions to FDA & other regulatory authorities.• Performing User Acceptance Testing (UAT Scripting) and Validating applications, Creating Test Scripts, Training Materials.• Information Security Change Management and Document Management process and tool support. • Lead Computer Validation and activities for an Extedo eCTD and SAS management system including writing validation documents.

Responsible for collaborating on all compliance initiatives associated with applicable FDA, ISO, and Sarbanes Oxley regulatory compliance issues and executing strategies for maintaining compliance with IT management, Internal Audit, and Corporate Regulatory.• Coordinating and maintaining audit management activities related to internal Audit findings, tracking, and evaluating audit responses.• Identifying areas of compliance risk and approaches to address those risks (Systems, process, and practices).• Providing regulatory perspective for each business structure on SAP ECC 6.0 global upgrade implementation.

Management of and improvement on the company-wide quality control system and regulatory affair for this biomedical device company. As an active member of the leadership team, Interfaced supported and defended the organization directly with internal and external regulatory auditors (FDA, ISO, Health Canada, and EU approvals). This company designs and distributes CAD (Computer Assisted Diagnosis) and MRA (Magnetic Resonance Angiography) software for medical imaging. • Provided supervision, maintenance, and regulatory guidance for audits performed by FDA, ISO, and European CE mark approvals. • Preparation and submission of regulatory documents for approval of 510k, IDE, and Pre-Market Approvals for Class II and III products.• Reviewed and approved product labeling, promotional, and advertising material/website. Load and regression testing with Quality Center.• Performed internal audit of QSR and business processes and maintained all regulatory requirements according to ISO 13485, 21 Part 820, 93/42/EEC, MDD, and CMDR. Created documentation for testing and validation of products in development.• Provided QSR guidance to I/S functional teams with the development, implementation of control processes, documentation, and compliance routines. Responsible for all change management activities. Performed employee training of quality systems regulations.• Developed requirements, forms, and procedures for Complaints and CAPA data management system (Track Wise).

Responsible for performing compliance, risk assessments, and periodic reviews for various clinical data/ information management systems such as eCTDXpress and Publisher for a newly acquired Bio-pharmaceutical corporation.• Performed Regulatory Assessments, Risk Assessments per ISO 14971, and Annual Periodic Reviews for products/information systems.• Tracked, communicated compliance and risk issues, and report findings to stakeholders. Utilized Microsoft SharePoint• Operational review of information systems processes against corporate, government, and internal information system standards.

- Responsible for leading business and technical requirements, definitions, and activities for qualifying and validating a new laboratory and installing new lab equipment. Developed sterilization protocols for new installation.• Ensured project requirements and business processes were identified, documented, and methodology deliverable timelines were met.• Developed process analysis, detailed requirements, specifications, and design documentation for LIMs system.• Prepared and developed of all validation deliverables for Ariol SL-50 and Cyto Vision image capturing equipment.

Create process documents and other technical documents that describe how future IT audits will be requested, sourced, and carried out by Pfizer worldwide. This relates to the audits that Pfizer has to do of software companies and vendors that have Pfizer work outsourced to them, etc. • Developed Third Party Compliance Requirements checklist/ for potential vendors to complete.• Help develop new approaches to solve problems identified during audit activities• Supported and consolidated legacy vendor audit material into a new harmonized service for Pfizer World Technology.

Developed and revised Process Validation documentation for this major biomedical device company. Work effectively with Staff to ensure that validation documentation meets FDA and European specification.• Developed and reviewed Product Specifications, Process FMEA’s, Design FMEA’s, Test Methods, Design Verification Protocols, IQ, OQ, and PQ reports according to EN ISO Standards, Corporate, and Site SOPs for several of their products.• Executed and supported process validation activities in manufacturing to ensure accuracy and integrity.• Reviewed drug safety data and customer complaints to generated reports for the Clinical Risk Benefit Analysis (CRBA).Contributed to the Validation and Qualification of a global Quality Management System NCE/CAPA process for Manufacturing, Calibration, Change Management, Customer Complaints, Process Automation, and Supplier Audits. Revised CAPA SOPs and forms to meet FDA requirements from issued 483 warning letters.• Developed recommendations for process improvement and present to company sponsors.• Supported QA and Manufacturing in complaint investigation to identify root causes of failures and process improvements.

Responsible for Quality Assurance review of validation and technical documents for ERP IT projects of their Clinical Trials Safety Data Management area. Performed data mapping, migration/conversion, and system interface controls of pharmacovigilence safety software for this pharmaceutical company. Validation of Drug Safety Reporting utilizing applications such as ARISg, Oracle, and EDMS. Interacted with the pharmacovigilence group to correlate adverse events.• Assessed general IT management issues including, planning/support, change management, release/deployment management, and disaster recovery as they relate to the ERP installations.• Advised, reviewed, and approved all corporate change/asset management and release management for upgrading equipment and software applications per ITIL Specification. Reviewed system specification for Medical Affair and Services per 21 CFR Part 11 and cGCP compliances.

Provided Validation Master Plans, Assessments, Gap Analysis, Corrective Action Plans, Remediation Plans, and Validation Summary Reports for automated equipment for building management systems, manufacturing, packaging, and computer systems per 21 CFR Part 11 compliance. Performed Internal Audits to identify quality systems gaps.• Wrote documentation deliverables for validation SDLC such as GxP Assessments, User Requirements Spec., Functional Requirement Spec., Design Spec., Remediation Plan, Formal Test Plan, IQ, OQ, PQ, Test Summary, Requirements Traceability Matrix, Validation Summary Report, and Document Index Registry for new and legacy computerized systems, such as Voltec Building Management Systems, WonderWare, USP Purified Water System, and Water for Injection System.• Executed protocols for automated equipment and computer systems that contain DCS, PID Controllers, and SCADA/PLC controls.

Developed and wrote corporate strategy and policies, World-Wide SOP’s and templates for validation and 21 CFR Part 11 Remediation project for this major pharmaceutical company under Consent Decree. Ensured that validation documentation met FDA and regulatory affairs specification. • Developed validation SOPs such as Security, Backup/Recovery, Data Archival/Retrieval, Problem Reporting and Change Control according to cGMP/GLP/GCP compliances. Wrote documentation deliverables for validation such as: GxP Assessments, User Requirements Spec., Functional Requirements Spec., Design Spec., Formal Test Plan, IQ, OQ, PQ, Test Summary, Requirements Traceability Matrix, Validation Summary Report, and Document Index Registry for new and legacy computerized systems. • Remediated CMC, manufacturing, packaging, and Laboratory systems such as the Delta, Checkweigher, Tablet Presses, and HPLC.

Established, developed, and managed four different Quality Assurance groups and programs for manufacturing and packaging of major consumer and pharmaceutical products in the client’s facility. The clients were Schering-Plough, Pfizer, Proctor & Gamble, also Johnson & Johnson. Developed/audited SOP’s, protocols, quality procedures, packaging, labels, and analyses to drive continuous improvement for point of purchase displays and packaging according to customer, GXP, and FDA requirements.

Worked effectively with operations for the development of packaging/shipping specifications for a high volume thermoform/plastic packaging/shipping manufacturer for Biomedical and Consumer products. Developed Six Sigma program to improved product quality. Extensive planning, budgeting, hiring, cGMP training, certifying, and managing supervisors and technicians.• Ensured that suppliers and contract manufactures were operating in compliance with FDA regulations such as 21 CFR Part 11, 210, 211 and 820 regulatory requirements/guidelines through an external audit program.• Represented company in FDA /client inspections and provided evidence of documentation to regulatory agencies.• Wrote and reviewed software validation System Development Life Cycle for Allen Bradley PLC/SCADA systems.

Responsible for all phases of incoming inspection, production, design testing, and final inspection. Introduced new procedures for procurement of raw plastic material and supplier-molded castings. * Directed senior staff on inspection, testing and approval/rejection of active /inactive materials, labeling and packaging materials, in-process materials and finished product.* Oversaw team members' milestones and performance as compared to the project plan, scope, and WBS.* Demonstrated ability to evaluate, plan, and implement projects within schedule and budget requirement