Senior QA Specialist - CSV

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Job Function:

Quality

Job Sub Function:

Quality Documentation

Job Category:

Professional

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

We are currently seeking a highly qualified individual to join our team as a Senior QA Specialist - CSV at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC).

Key Responsibilities:

• •Program build: Author, implement, and maintain site CSV and data integrity procedures; contribute to the Validation Master Plan, computerized system inventory, and GxP/criticality assessments.
• •Project QA oversight: Represent Quality Assurance on qualification teams across requirements, design review, construction, commissioning, qualification, and implementation to ensure quality, regulatory, engineering, safety, and process requirements are met for technologies being established at our greenfield site (including AI-enabled inspection, ASRS, AMRs, digital validation, and connected manufacturing systems). Provide consulting to the project management team to ensure appropriate quality systems are in place for new systems.
• •Risk-based validation: Apply GAMP 5 (2nd Edition) critical thinking, ICH Q9(R1), and ASTM E2500 principles to integrate commissioning and qualification, leverage supplier documentation and FAT/SAT evidence, and right-size testing based on risk to patient safety, product quality, and data integrity.
• •Lifecycle deliverables: Review and approve URS, FRS, HDS, SDS, configuration specifications, Unit Integration Testing, FAT, SAT, IQ, OQ, PQ, risk assessments, Requirements Traceability Matrix, data integrity assessments, data/process flow diagrams, supplier assessments, interface and integration testing, code reviews, deviations, validation master plans, and validation summary reports, as needed.
• •Traceability and release: Ensure all requirements are properly traced, tested, and qualified across the project lifecycle, and that facilities, utilities, and systems are properly released for use in GMP manufacturing.
• •Deviations and exceptions: Ensure all deviations and test exceptions are properly documented, evaluated, approved, and closed across project testing phases; lead or support investigations and CAPAs.
• •Data integrity and cybersecurity: Establish and oversee audit trail review, access management, backup/restore, archiving, and data lifecycle controls in accordance with 21 CFR Part 11, EU GMP Annex 11, and ISA/IEC 62443 (including OT/IT network segmentation).
• •Advanced and AI-enabled technologies: Provide QA oversight of AI/ML-enabled inspection systems, including training and test data governance, performance metrics, static (locked) models, and model change control, as well as automated visual inspection aligned with USP / .
• •Annex 1 alignment: Ensure validation of EMS/PAS alarm and audit trail functionality, isolator decontamination cycle automation, and system data that supports the site Contamination Control Strategy.
• •MES and execution systems: Oversee qualification of MES/electronic batch records, including ISA-88 recipe management, review by exception, and ISA-95 integration across MES, ERP, LIMS, and automation layers; ensure alarm management practices align with ISA-18.2.
• •Supplier oversight: Assess and audit system integrators and platform suppliers (DCS/PLC, MES, LIMS, AVI, serialization) and cloud/SaaS providers, including quality agreements and service level expectations.
• •Change control: Evaluate the potential impact of process or system changes on product quality, and support upgrades, modifications, or changes to GxP system components from a quality, compliance, data integrity, and cybersecurity perspective.
• •Operational readiness: Lead the project-to-operations handover, including system ownership, periodic review, operational change control, and incident/problem management; ensure systems maintain their validated state through periodic review and revalidation as necessary.
• •Inspection readiness: Ensure systems and data are ready for pre-approval and pre-license inspections by FDA, EMA, and other regulators, including preparing system narratives and leading system demonstrations.
• •Escalation and continuous improvement: Report and escalate quality risks/issues to the Quality Leadership team; implement lessons learned and best practices from other internal and external projects.
• •Training and capability building: Train personnel in Computerized Systems Operations and Maintenance, and mentor team members to build CSV capability across the site organization.

Required:

• •A Bachelor's degree in a scientific, engineering, or computer science discipline.
• •A minimum of 6 years’ relevant experience working within the biological and/or pharmaceutical industry, with substantial hands-on experience in computerized system validation or computerized system quality assurance.
• •Hands-on experience with QA oversight of CSV for automated manufacturing equipment and systems (PLC/DCS/SCADA/MES) and GMP laboratory systems (e.g., LIMS, CDS).
• •Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (2nd Edition), and data integrity expectations (FDA, MHRA, PIC/S, WHO).
• •Demonstrated application of risk-based, critical-thinking approaches to validation (GAMP 5 2nd Edition, ICH Q9(R1), FDA Computer Software Assurance principles), including leveraging supplier documentation and avoiding duplicate testing.
• •Experience with Software Development Life Cycle (SDLC) and the qualification of facilities, utilities, and equipment, including integrated commissioning and qualification (ASTM E2500).
• •Experience leading or supporting deviations, investigations, and CAPAs.

Preferred:

• •Validation experience with sterile fill-finish, isolator or RABS automation, and EMS/PAS systems supporting EU GMP Annex 1 and a Contamination Control Strategy.
• •Experience with automated visual inspection (USP / ) and validation of AI/ML-enabled systems.
• •Experience with combination products or device assembly (21 CFR Part 4, 21 CFR Part 820/QMSR, FDA Computer Software Assurance guidance), or with serialization (DSCSA, EU FMD).
• •MES/electronic batch record experience, including ISA-88 recipe management, review by exception, and ISA-95 enterprise integration.
• •Knowledge of OT cybersecurity (ISA/IEC 62443), alarm management (ISA-18.2), and cloud/SaaS supplier oversight.
• •Familiarity with ICH Q10, EU GMP Annex 15, and the evolving EU GMP Annex 11 revision and Annex 22 (Artificial Intelligence).
• •Greenfield, start-up, or large capital project experience.
• •Experience supporting FDA, EMA, or other regulator inspections, including pre-approval or pre-license inspections.
• •Experience with digital validation tools (e.g., Kneat, ValGenesis) and platforms such as DeltaV, Rockwell, Siemens, PAS-X or Syncade, LabWare, Empower, OSIsoft PI, and SAP.
• •Strong technical writing skills.

Key Competencies:

• •Integrity and quality mindset: High integrity and commitment to operating ethically within regulatory requirements; promotes a culture of quality.
• •Sound judgment: Makes pragmatic, risk-based decisions independently, solves complex