Senior Manager, Drug Product Optical Inspection System User

Johnson & Johnson Innovative Medicine•Wilson, NC

11d•Onsite

About The Position

This role is part of a new team at Johnson & Johnson's Innovative Medicine division, focusing on parenteral Drug Product sites. The position will drive the end-to-end recruitment ramp-up strategy for optical inspection systems, aligning with project timelines and budget. Initially a single contributor role, it will evolve into a Senior Production Manager role with responsibility for the Optical Inspection operations team. The company emphasizes health innovation, patient focus, and a diverse, inclusive work environment.

Requirements

Bachelor’s or higher degree in Life Sciences, Pharmacy, or Engineering is required.
A minimum of 8 years of experience in the pharmaceutical industry, including people leadership, is required.
Minimum of 3+ years serving as the recognized Subject Matter Expert in Optical Inspection for parenteral filled products, including 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 ability to evaluate, select, implement, and standardize advanced technologies across processes while staying current with emerging industry tools and platforms.
Demonstrated thought leadership and innovation, with a track record of originating, championing, and implementing novel technical solutions to complex operational and quality challenges.
Exceptional interpersonal and influencing skills, with the ability to act as the go‑to technical authority across cross‑functional, site, and global teams, effectively guiding decisions without direct authority.
Proven ability to analyze highly complex, ambiguous problems, synthesize data and risk, and formulate clear, defensible technical positions in fast‑paced and evolving environments.
High adaptability and resilience, with the capacity to lead through changing priorities, evolving project scopes, and operational challenges while maintaining high technical and compliance standards.
Strong stress tolerance and decision‑making capability, consistently balancing business urgency with patient safety, compliance, and sustainable ways of working.
Entrepreneurial and ownership mindset, proactively identifying opportunities, driving continuous improvement, and taking calculated, data‑driven risks aligned with quality and business objectives.
An approach that recognizes opportunities and is willing to take calculated risks, and encourages entrepreneurial thinking.

Nice To Haves

Master's or higher degree is preferred.
Lean/Six Sigma certifications

Responsibilities

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.