Manage the Data Integrity (DI) program and the Digital Quality (dQ) oversight of Digital Systems (Computerized and Software Systems including Laboratory Instrumentation) across all phases of the System Development Lifecycle at the Resilience’s RTP Facility.•Ensure site adherence to Data Integrity through training, assessing, remediation, and governance. .•Drive DI Corrective and Preventive Actions (CAPAs) to reduce and eliminate repeat DI events.•Review and approve site Digital and Infrastructure implementation changes.•Review and approve life cycle documentation, Change Controls, Validation Plans, URS, FRS, etc. •Lead and collaborate with site cross-functional team to assist in establishing alignment, harmonization, and standardization with corporate-wide Digital Systems Governance Programs (such as SDLC, Data Integrity, Risk Management, Periodic Reviews, and others)•Ensure site Quality and compliance with GxP activities concerning internal and/or customer procedures as well as FDA, ICH, EU, and country-specific regulations. •Lead/conduct/oversee training of Resilience personnel on Electronic Records (21CFR11), CSV, Data Integrity, and relevant Quality SOPs at the site level.•Co-lead global Digital Governance Board and Represent site dQ at site quality leadership and site Quality Review Board to enable the adoption of corporate dQ and Data Integrity standards. •Assess and advise SMEs on maintaining systems in a state of inspection readiness. •Establish and report to site leadership and corporate leadership on site-based dQ/DI KPIs.•Drive the assessment and risk management and remediation strategy and execution plan for DI controls (including testing) of digital systems procured by and/or designed/developed in-house at Resilience; collaborate with site stakeholders and central DI program lead to institutionalizing on-site. •Define appropriate DI controls as part of purchasing and implementing equipment/systems and processes.

Manage global team to meet business objectives for new instrument induction, data integrity (DI) remediation of computerized systems, and day-to-day operational support. Collaboration and support with Global IT operation, IT Enterprise Leadership, Architecture, Product Development, Manufacturing, Lab Systems and Quality groups to execute strategy, design, and implementation of industry best practices and solutions. Responsibilities and activities include:• Lead, manage, and provide technical guidance globally to 5 direct reports and 4 contractors for Level 3 Lab Support of lab and manufacturing computerized systems using Managed Engine ticketing system.• Lead and support lab and manufacturing instrument validation and computerized system configurations following established GxP and organization policies.• Use Agile methodologies through Atlassian (JIRA) software to track and manage projects and track instrument implementations and remediations.• Ensure team members adhere to documented System Development Life Cycle as well as relevant regulations, policies, and standards.• Lead and Support IT Investigation to identify root causes of issues related to lab and manufacturing systems and implement effective CAPAs and ECs to prevent future occurrences and implement proactive monitoring to ensure early warnings and quick recovery.• Lead and support Data Integrity (DI) assessment and drive remediation solution of computerized systems and processes through Change Controls and or CAPAs for Lab and Manufacturing systems using ALCOA+ principles.• Manage all computerized analytical instrument and systems administration SOPs.• Communicate with all levels of management and across all functional areas regarding Lab IT support priorities and project statuses.• Subject Matter Expert for laboratory and manufacturing COTs systems and enterprise applications including Empower, Wonderware, SoftMax Pro, and WinLab UV.

Performed quality computerized system lifecycle management from concept, development, validation, implementation, and maintenance to retirement. Responsibilities and Activities included:• Managed Global Change Controls for Software validation on QC computerized systems• Provided SME oversight to all QC equipment qualification and validation • Reviewed and approved validations of Computerized Off the Shelf (COTS) System and Enterprise (Server Based) Systems in the QC and Manufacturing area• Created System Specifications, System Administration SOPs and FORMs related to the QC computerized systems using ACE and ESOPS repositories.• Supported cross functional teams by selecting new computerized systems for use in QC and Manufacturing areas• Provided Technical support for alignment of computerized systems globally across Novartis Gene Therapies• Led global team to create a process to verify software templates used in release of product to support closing Non-Conformance Reports (NCR) and CAPAs• Provided SME technical support for Waters Empower 3 and HPLC systems• Provided SME technical support for Molecular Devices SoftMax Pro GxP Software and Plate Reader• Supported administrative activities in STAR LIMS system• Supported data integrity initiatives as they relate to the implementation of new and remediation of existing computerized systems.

Performed Computer System Validation (CSV) and Implementation Activities of Analytical Instruments per 21CFR part 11 in the QC Laboratories and Manufacturing at Biogen. Responsibilities and Activities included:• Led cross functional and global projects related to validation, decommissioning, and Data Integrity (DI)/remediation of analytical instruments and software using ALCOA+ principals• Supported QC Management with budgeting for new instruments and remediation activities for existing instruments• Site liaison with Global and consultants for implementation and use of Analytical Instruments• Managed Global Change Controls (GCC’s) using Product Lifecycle Management (PLM) software for validation and decommissioning of analytical instruments• Drafted Requirement Specifications (RS), Installation, Operational, and Performance (IOPQ) documentation related to implementation of CSVs and analytical instruments within QC and Manufacturing environments using KNEAT• Executed IOPQ test scripts related to CSVs and Analytical Instrument within QC and Manufacturing environments using KNEAT• Managed Computer Systems and Analytical Instrument lifecycles in EAM.• Performed Data Remediation/Integrity activities on existing CSVs and Analytical Instruments

Performed Computer System Validation (CSV) and Implementation Activities of Analytical Instruments per 21CFR part 11 and GAMP5 in the QC Laboratories and Manufacturing at Biogen. Responsibilities and Activities included:• Led cross functional and global projects related to validation, decommissioning, and Data Integrity (DI)/remediation of analytical instruments and software using ALCOA+ principals• Supported QC Management with budgeting for new instruments and remediation activities for existing instruments• Site liaison with Global and consultants for implementation and use of Analytical Instruments• Managed Global Change Controls (GCC’s) using Product Lifecycle Management (PLM) software for validation and decommissioning of analytical instruments• Drafted Requirement Specifications (RS), Installation, Operational, and Performance (IOPQ) documentation related to implementation of CSVs and analytical instruments within QC and Manufacturing environments using KNEAT• Drafted, executed, reviewed, and approved IOPQ test scripts related to CSVs and Analytical Instrument within QC and Manufacturing environments using KNEAT Validation Software• Managed Computer Systems and Analytical Instrument lifecycles in Electronic Access Management (EAM).• Traveled to other sites globally to performed data remediation/integrity activities on new and existing CSVs and Analytical Instruments

Performed Quality Control testing of Biogen and partner products within the cGMP Biochemistry laboratory. Responsibilities and activities included:• Served as single point of contact for instrument, processing, and reporting of HPLC/UPLC methods via Empower 3 data acquisition software• Provided quality oversight to junior personnel in method management and troubleshooting activities. • Served as the SME for SEC a, Ion Exchange and Reverse Phase HPLC methods• Performed semiannual and annual PMs on Perkin Elmer UV spectrophotometers• Reviewed and approved QC Method Validation Protocols and Reports• Performed Determination of percent Oxidation and Deamidation by Reverse Phase chromatography• Performed Determination of percent sialylation by reverse phase HPLC• Performed Determination of Osmolality, pH, and Appearance by visible inspection• Drafted and edited SOPs, Forms and other documents in the eDocs and myCIMs database systems• Performed initial lab assessments and documented investigations using TrackWise • Prepared control reports to document the preparation or extension of assay controls and standards.• Performed and documented assay testing using the LabWare Laboratory Information Management System (LIMS)

Performed testing, editing of SOP documentation and forms, and review of data for successful transfer and implementation of Ultra Performance Liquid Chromatography (UPLC) QC methods to the Holly Springs manufacturing facility.• Responsibilities and activities included: Determination of carbonyl compounds by reverse phase HPLC analysis.• Determination of quantitation of particles by laser particle analyzer type AccuSizer 780A • Determination of mean particle size by using the Nicomp 380 Particle Analyzer per dynamic light scattering technique• GMP Quality review of Laboratory Documentation• GMP SOPs and Forms creating and editing using Atlas Livelink

Performed quality control testing of the following products in the Quality Control Chemistry laboratories at Wyeth Vaccine; Pneumoccal 7-valent Conjugate Vaccine and the Haemophilus b Conjugate Vaccine Assays and Techniques Include:• Documentation of assay testing using the Laboratory Information Management Systems • Performed Free Protein and DMSO Analysis using Agilent 1100 HPLC • Received Expert on the Job Training Certificate• Performed Aldehyde Analysis – Park-Johnson, AHMT, O-Acetyl• Performed Water Analysis through pH and Conductivity testing• Performed Protein Analysis using Lowry, Soluble Protein, Modified Borate Lowry assays• Performed Sugar Analysis using Anthrone and Nana assays• Operated UV-Vis Spectrophotometers and Centrifuges, • Performed Nucleic Acid Content Analysis,• Performed Diafiltration of Sucrose, • Performed Cyanide Analysis, • Performed Do, DP, and Free Sugar Analysis,• Prepared KD Columns