Robert Redmond Email & Phone Number

San Diego, California, Us

Senior leader for all Quality Operations activities.Ensures quality and compliance of all manufacturing and testing activities to support release of product.Directly manages the Quality Operations/Systems, Validation and Compliance groups.Collaborates with Operations, Facilities, Metrology, Quality Control, Microbiological, and Project Management leadership.Identifies and KPIs.Facilitated implementation of QMS business tool for enhanced oversight of Quality Events.Directs and manages site client audits and interfaces.Directs and manages all internal audit programs.Facilitates and manages all site product complaints.Identifies and provides leadership on all compliance related activities.Manages monthly Quality Management Review (QMR). Represents site at quarterly Global QMR.Partners with Global Quality Systems group to support site needs around Compliance, Inspection Management, Training and Audits (internal, external and client).Identifies process improvements across the Quality organization. Aligns with Global Quality Systems group to support and implement areas for improvement.Facilitates cross-functional partnerships on Quality and Compliance activities.Assists in maintaining compliance with the Quality Management Systems.Authors, reviews, and approves SOPs, protocols, reports, and other Quality records for accuracy and compliance with all applicable regulations and international standards.Writes, reviews, and approves discrepancy reports (e.g. deviations, CAPAs, complaints, etc.).Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.Provides site GMP training to cross-functional departments.Evaluates the effectiveness of corrective actions.Coordinates, performs, and tracks risk assessments.

Fort Worth, Texas, Us

Serves as the Quality Assurance and Systems Subject-Matter-Expert (SME).Manages three teams: (Batch Release, Quality Systems, and Plant QA) with three (3) direct reports and 22-indirect reports.Facilitates and supports Health Authority inspections inclusive of host and writing corrective action responses. Identifies, assigns, and provide Quality Assurance enhancements to the Preventive Maintenance, Deviation Management, Complaints, and Change Control systems. Ensures that all manufacturing, packaging, and labeling deviations, Change Controls, and Investigations are completed within the specified timeframe and provides metrics/trends as required.Develop, maintain, and issue Quality Metrics.Supports Quality Assurance to guide various projects and technical meetings, as needed.Develops, reviews, and approves Standard Operating Procedures (SOPs); Quality Manufacturing protocols, as required; Manufacturing, Packaging, and Labeling records; Quality Validation and Research and Development documents, as required.Ensures and maintains the organizations compliance with Food and Drug. Administration (FDA) 21 CFR Part 4, 11, 210, 211, and 820 compliances.Ability to monitor and report on assigned tasks, goals, and objectives.Review and ensure that Annual Product Reviews (APRs) are completed and approved as per SOP and requirements.Ensures the Internal Audit program is maintained.Ensures the Vendor Qualification program is maintained.Supports customer audits.Provides leadership and oversight to Batch Development and Release activities.Provides leadership and oversight to product manufacturing Quality activities.

San Antonio, Tx, Us

Plan, manage, and provide team leadership to support Regulatory & Compliance activities at the multi-manufacturing site level. Develop and authorize the implementation of site policies and procedures to assure compliance with government requirements (FDA, EU, MHRA, etc.), and corporate policies. Participate as a member of the site Manager Teams developing site strategies, policies, and successfully implementing the same. Work with Quality Staff to assure alignment of policies and procedures between and within sites. Must be able to represent the company with customers and regulatory agencies.Site Compliance :Ensure sites are compliant with applicable quality and regulatory requirements for cGMP, QSR, and cGLP regulations.Inspections and Audits: Manage FDA, MHRA, (and other regulatory bodies) and Customer Audits. This includes preparation for and managing responses to FDA and client audit reports, managing CAPA, and tracking other regulatory commitments for any of the company manufacturing sites. Management of internal Self Inspection program.Regulatory Expertise: Develop and maintain regulatory expertise and knowledge of industry trends. Advise the organization in matters relating to cGMP, QSR, NDA/OTC requirements, and other regulatory policies and changes being implemented by regulatory agencies.Vendor Audits: In conjunction with Global Auditing, Purchasing and QC, identify and manage vendor and service provider audits. Ensure the audit, whether performed by a company auditor or a contracting firm, addresses regulatory requirements. Manage corrective actions.Quality Agreements: Develops standard quality/technical agreements and manages these agreements in conjunction with customers, vendor and contract lab facilities.Budgets: Develop and manage budgets for the Compliance Team in support of business initiatives and strategies

Dublin, Ireland, Ie

Responsible for corporate Quality Systems and Compliance manufacturing facilities, ensuring regulatory compliance to FDA, ANVISA, TUV, EMA and MHRA standards are maintained.Oversight of manufacturing site regulatory compliance and resolution of regulatory compliance concerns.Identification and management of regulatory compliance enhancements plans.Assist in Regulatory Inspections.Due diligence and integration management of Quality Systems due to business merger and acquisitions.Manages Internal Quality Systems/Compliance and CMO audit programs, training and documentation management programs and groups, develops and manages departmental budget, and develops and implements corporate policies and procedures.Assist in the Supplier Audit program.Conducts review of staff, offering suggestions for improvement and greater accountability.Identifies and implements cost reduction and Quality/Compliance Improvement plans.

Sant Cugat Del Vallès, Barcelona, Es

Prepared 147 Grifols owned and 28 contracted plasma collection facilities for regulatory inspections, and executed audits ensuring compliance with FDA, GMP, RPD and EMA regulatory standards. Performed special investigations, approved equipment validation summary reports, and worked with business units to identify and mitigate client safety, product quality, and regulatory compliance risks and concerns.Hosted RPD and EMA European inspection agencies, and assisted in hosting FDA Inspections.Assisted in special project teams to ensure resolution of plasma donation facility remediation and regulatory licensing, and compliance with FDA and GMP expectations.

Waltham, Massachusetts, Us

(Previously Banner Pharmacaps, Inc.)Served as Corporate Compliance and QA representative, spearheading customer and FDA interactions and audits, ensuring compliance to regulatory standards at 4 manufacturing sites located throughout the world. Responsible for implementation, management and approval of customer Quality Agreements, in addition to the facilitation of all responses and follow-up to regulatory (FDA) and customer audit observations.Managed GMP, GLP and regulatory compliance at manufacturing sites, tracked monthly QA matrix consisting of key performance indicators, and developed and Implemented quality improvement programs.Developed, implemented and managed vendor audit and selection, certification programs and training database, and audited Operational and Quality Assurance Units to ensure GMP and regulatory compliance.Created and spearheaded a quality control reduced testing program at the High Point manufacturing facility. Reviewed and approved CAPA elements for process improvement, and equipment and manufacturing validation protocols and reports, and developed and implemented regulatory and customer corrective actions. Developed, supervised, motivated and trained staff of 4, ensured their timely completion of tasks, and identified and resolved quality and technical problems.

Waltham, Massachusetts, Us

(Previously DMS Pharmaceuticals)Scheduled and conducted external audits of contract testing laboratories and raw material suppliers. Responsible for vendor audit and certifications program performance, including vendor approval or rejection, and managed documentation required to conduct follow-up audits and supplier approval.Produced and maintained approved suppliers list, assisted in approved vendor investigations, and initiated quality improvement plans to resolve material and service concerns.Supervised support staff, identified training needs and developed training programs, and provided direct quality support to 4 business units and corporate management.Prepared, reviewed and approved audit reports, procedure and batch record documents.Served as principle QA liaison for customer negotiations on Quality Agreements and resolution of significant validation, product and regulatory issues identified by 3rd party customer audits and regulatory inspections.Evaluated new regulations, changes to existing regulations and regulatory trends, and performed GAP analysis to determine deficiencies and make appropriate adjustments.Prepared the business units for inspections conducted by regulatory agencies such as the FDA, MCA and EMA.

Toronto, Ontario, Ca

Managed review and approval process of all R&D and clinical trial data obtained by outside contractors, and coordinated with Project Management and Regulatory Affairs on project development and clinical trials status. Ensured that raw material and stability testing for Finished Products was performed within specified time frames and complied with specifications.Facilitated Safety and GMP training to employees by reviewing, approving and training all staff on internal SOP’s prior to implementation, and assisting in the audit of internal, external, clinical and contract facilities.Supervised QA auditors, documentation specialists and QC scientists, and chaired the Compendia Review Committee to identify commonalities and differences on tests and test methodologies.Audited internal reports, lab data and contracted research organizations by supporting FDA submissions and responses, and by writing, approving and implementing Standard Operating Procedures.Coordinated and supervised QA auditors, and conducted and provided GMP training.

Master Of Business Administration (Mba), Training And Development

Bachelor Of Arts (B.A.), Chemistry