Senior Manager, Drug Product Optical Inspection System User

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at more and apply to this exciting new role!

As a member of this new team the role will partner closely with parenteral Drug Product sites across the J&J network and will own and drive the endtoend recruitment ramp-up strategy delivering results in alignment with project timelines and budget commitments. This role will transition from a single contributor role into a Senior Production Manager role with responsibility for the Optical Inspection operations team.

Key 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 safetyrelated 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.

Qualifications

Education:

• Bachelors or higher degree in Life Sciences Pharmacy or Engineering is required; a Masters or higher degree is preferred

Experience and Skills:

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.

• Expertlevel knowledge of cGMP regulations with a proven record of leading inspections audits and regulatory interactions authoring and approving qualitycritical 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 goto technical authority across crossfunctional 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 fastpaced 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 decisionmaking 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 datadriven risks aligned with quality and business objectives.

• An approach that recognizes opportunities and is willing to take calculated risks and encourages entrepreneurial thinking

Preferred:

• Lean/Six Sigma certifications

Other:

• This position will be located in Wilson North Carolina and will require full time on-site support. However the design of the facility will occur at an Engineering firm with frequent travel (> 75%) required until the project shifts to the plant site of Wilson NC.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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