Manager, Quality Control
Role reports to:Site Quality Director
Location:North America, United States, Pennsylvania, Fort Washington
Work Location:Fully Onsite
What you will doThe Manager, Quality Control is responsible for leading the site analytical laboratory and ensuring compliant, reliable, and timely testing in support of Fort Washington operations. The role oversees analytical testing of components, in-process materials, finished products, cleaning validation samples, and marketed-product stability samples. This leader ensures laboratory activities comply with current Good Manufacturing Practices (cGMP), all applicable environmental/health/safety laws and regulations, company standards, and applicable regulatory requirements while developing people, improving laboratory performance, and supporting site priorities.
Key Responsibilities- Lead all analytical laboratory activities supporting components, in-process materials, finished products, stability, equipment-cleaning validation, and other site testing needs. Ensure work is performed safely, accurately, on schedule, and in accordance with approved procedures, specifications, cGMP, and data integrity expectations.
- Exercise appropriate laboratory decision-making authority, including escalating significant compliance, product quality, and data integrity concerns; placing testing, equipment, or laboratory activities on hold when warranted; rejecting analytically invalid work; and recommending interruption of laboratory operations when continued activity may affect compliance or product quality.
- Plan and schedule laboratory work to optimize the use of people, equipment, materials, and external testing resources. Forecast staffing, capability, and equipment needs in advance of operational and regulatory demand.
- Oversee qualification and requalification of analytical equipment and the laboratory calibration and preventive maintenance programs. Ensure laboratory equipment and systems remain suitable for their intended use.
- Provide oversight for applicable laboratory computerized systems, including LIMS and Empower, and ensure compliant use of electronic records and automated processes. Oversee laboratory data governance, review of electronic data and audit trails, appropriate system access and role controls, segregation of system-administration and operational responsibilities, and periodic review of laboratory computerized systems.
- Review or approve analytical method transfer, qualification, validation, and related protocols and reports, as applicable. Provide technical oversight for wet chemistry and instrumental analysis activities.
- Monitor, assess, and implement applicable changes to USP/NF and other relevant pharmacopeial requirements, regulatory expectations affecting analytical laboratory controls, and global laboratory standards and procedures.
- Ensure adequate resources and timely, scientifically sound execution of laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) investigations. Participate in or review root-cause analyses, nonconformances, change controls, risk assessments, and other quality records; oversee development and implementation of appropriate corrective and preventive actions (CAPAs), evaluate CAPA effectiveness, and ensure timely escalation of potentially reportable or product-impacting results and significant issues through effective closure.
- Establish, monitor, and interpret laboratory and site metrics to identify signals, improve right-first-time performance, strengthen reliability, reduce cycle time, and support annual product and quality system reviews.
- Maintain the analytical laboratory in a state of inspection readiness. Serve as a laboratory subject matter expert during internal audits, corporate audits, and regulatory health authority inspections, and contribute to inspection responses and follow-up commitments.
- Lead, coach, and develop laboratory employees. Set priorities, clarify accountability, maintain training and qualification, support performance and development discussions, and foster an inclusive culture of open communication, ownership, collaboration, and continuous learning.
- Partner with Quality Assurance, Manufacturing, Engineering, Validation, Regulatory Affairs, R&D, Supply Chain, EHS, vendors, and contract laboratories to resolve issues and support new product introductions, technology transfers, post-approval changes, validation activities, and site initiatives.
- Develop and manage laboratory operating and capital budgets. Identify, prioritize, and implement continuous improvement opportunities using Lean and operational excellence principles.
- Perform other related duties as required.
What we are looking forRequired Qualifications- Bachelor's degree in Chemistry or another relevant natural science.
- Minimum of 8 to 10 years of experience in the pharmaceutical industry or another highly regulated industry.
- Minimum of 3 years of supervisory or people-management experience.
- Experience leading or providing substantial oversight of Quality Control analytical laboratory operations.
- Thorough understanding of wet chemistry and instrumental analysis.
- Demonstrated knowledge of Drug cGMP requirements, laboratory controls, data integrity, and regulated documentation practices.
- Experience with laboratory investigations, analytical methods, equipment qualification, calibration, preventive maintenance, and inspection readiness.
- Strong leadership, prioritization, resource-planning, influencing, facilitation, oral communication, and written communication skills.
Desired Qualifications- Advanced degree in Chemistry, Pharmaceutical Science, Business, or a related discipline.
- Experience overseeing a laboratory equipment qualification, calibration, and preventive maintenance program.
- Experience with analytical method transfer, qualification, validation, and validation of analytical computerized systems.
- Experience interacting with or supporting inspections by regulatory health authorities.
- Working knowledge of LIMS, Empower, SAP or another ERP system, electronic records, and Microsoft Office applications.
- Knowledge of statistical concepts, data trending, capacity planning, Lean principles, and continuous improvement methods.
- Experience supporting new product introductions, technology transfers, stability programs, cleaning validation, or post-approval changes.
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What's in it for youAnnual base salary for new hires in this position ranges:
$124,100.00 - $175,200.00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
- Competitive Benefit Package*
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
- Learning & Development Opportunities
- Kenvuer Impact Networks
- This list could vary based on location/region
*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
