Senior Manager, Drug Product Optical Inspection System User

Job Function

Supply Chain Manufacturing

Manufacturing Pharmaceutical Process Operations

Professional

Wilson, North Carolina, United States of America

• Serve as the recognized Subject Matter Expert (SME) for Optical Inspection across the Drug Product facility, providing end-to-end technical ownership for manual and automated visual inspection processes for parenteral products.
• Lead and actively participate in all safety-related reviews (HAZOP, machine safety, ergonomic and human-factors assessments), with specific focus on inspection systems, operator interfaces, and defect-handling risks.
• Own the review and approval of User Requirement Specifications (URS) for optical inspection systems, ensuring alignment with cGMP, global regulatory expectations, inspector qualification requirements, and product quality standards.
• Review and approve engineering deliverables from concept through detailed design (e.g., PFDs, P&IDs, functional design specifications, equipment and automation specifications), acting as the final technical authority for inspection-related decisions.
• Define, govern, and continuously improve defect libraries, inspection standards, acceptance criteria, and inspection strategies, including challenge and approval of critical defect classifications and assumptions.
• Author, review, and approve process support and operational documentation, including Master Batch Records, SOPs, Work Instructions, inspection test kits, defect standards, and inspector qualification materials.
• Provide active on-site support during commissioning, qualification, and validation activities, including engineering studies, water and engineering batches, aseptic process simulations (APS), and validation batches, ensuring inspection readiness and compliance.
• Lead the preparation, execution, review, and approval of validation documentation related to optical inspection systems, including IQ/OQ/PQ, inspector qualification, and ongoing performance monitoring.
• Act as the quality-facing SME during regulatory inspections, audits, and internal reviews, confidently representing inspection strategies, data integrity, and compliance posture, and driving resolution of complex inspection-related observations.
• Ensure digitalization, automation, and robotics solutions for inspection are appropriately evaluated, selected, implemented, and standardized, staying current with emerging technologies and industry best practices.
• Identify required spare parts, critical components, and consumables for optical inspection and associated support systems, coordinating procurement and lifecycle management with engineering, operations, and supply chain partners.
• Ensure delivery of all inspection-related activities within approved budget and project schedules, proactively identifying and mitigating technical, regulatory, and operational risks.
• Monitor and verify that all user requirements, regulatory expectations, and quality commitments are met, including timely completion of information requests, documentation approvals and readiness milestones.
• Develop and execute training and qualification plans for inspectors, engineers and operations personnel, ensuring sustained inspection capability and compliance.

Bachelor’s or higher degree in Life Sciences, Pharmacy or Engineering is required; a Master’s or higher degree is preferred.

• Minimum of 8 years of experience in the pharmaceutical industry, including people leadership.
• Minimum 3+ years serving as the recognized SME in Optical Inspection for parenteral filled products, with deep expertise in manual and automated visual inspection systems, test kits, defect libraries and inspector qualification programs, with authority to define standards, challenge assumptions and approve final decisions.
• Expert-level knowledge of cGMP regulations, with a proven record of leading inspections, audits, and regulatory interactions, authoring and approving quality-critical documentation and successfully resolving complex compliance gaps as the accountable SME.
• Advanced expertise in digitalization, automation and robotics technologies, with a demonstrated…