Sr Manager Quality Control

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JOB DESCRIPTION

Position Title: Senior Manager Quality Control

Department Name: Quality Control

Reports To: Site Quality Head

Location: Malvern (primary) and Spring House (secondary) Pennsylvania

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.

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The Senior Manager Quality Control (QC) is a strategic multi-site people leader accountable for the compliant reliable and efficient operation of QC testing laboratories supporting biotherapeutic and advanced therapy programs at Malvern and Spring House. This position is a member of the Site Quality Leadership Team and reports directly to the Site Quality Head. The role provides end-to-end oversight of laboratory operations supporting clinical and commercial products including testing strategy method lifecycle data review investigations capacity resources and inspection readiness.

The Senior Manager leads an organization of 80 full-time employees and contractors across both sites. This leader establishes an integrated operating model develops leaders and technical talent ensures timely delivery of high-quality test results and partners with Manufacturing Quality Assurance Analytical Development Technical Operations Supply Chain Regulatory and external laboratories to protect product quality patient safety and supply continuity. The incumbent is expected to serve as a competent delegate for the Site Quality Head as assigned.

Key Responsibilities:

People Leadership & Strategy

• Lead develop and retain a multi-site QC organization of 80 full-time employees and contractors including managers supervisors analysts and support roles.

• Set the QC vision organization design operating model goals performance expectations succession plans and workforce strategy for Malvern and Spring House.

• Exercise leadership authority for talent acquisition performance management development recognition compensation recommendations promotions employee relations organizational design and appropriate corrective actions in partnership with Human Resources.

• Build a culture of quality safety accountability inclusion technical excellence collaboration and continuous improvement.

Multi-Site QC Laboratory Oversight

• Provide integrated oversight of QC testing laboratories supporting biotherapeutics and advanced therapies including cell and gene therapy programs across Malvern and Spring House.

• Ensure accurate and timely sampling testing review approval and reporting for raw and incoming materials in-process samples drug substance drug product release stability environmental and utility monitoring validation studies reagents media and buffers as applicable.

• Oversee sample management reference standards critical reagents laboratory inventory and the qualification calibration maintenance and lifecycle management of QC equipment.

• Oversee the lifecycle of diverse analytical platforms and assays including identity purity potency safety microbiological molecular cell-based and compendial methods with appropriate controls for complex and time-sensitive advanced therapy products.

• Ensure effective execution of method development support qualification validation transfer and verification activities together with QC support for Process Performance Qualification Continued Process Verification and product comparability.

Compliance Data Integrity & Laboratory Performance

• Maintain laboratory compliance with applicable cGMP requirements global quality standards approved procedures data integrity principles and health safety and environmental expectations.

• Ensure robust governance and timely closure of nonconformance investigations invalid assays out-of-specification and out-of-trend results laboratory investigations CAPAs change controls method transfers qualifications and validations.

• Maintain validated reliable and inspection-ready computerized laboratory systems including eLIMS Empower and other systems used for sample instrument method and data management.

• Provide accurate QC data and trend analyses for annual product reviews quarterly management reviews Continued Process Verification investigations regulatory submissions and product quality complaint assessments.

• Establish and monitor leading and lagging metrics for testing delivery right-first-time performance backlog cycle time capacity compliance and reliability; lead recovery and risk-mitigation plans when performance is off target.

Technical Strategy Business Partnership & Inspection Readiness

• Define and execute the multi-site QC strategy including laboratory capacity headcount and contractor planning scheduling asset and facility needs digital laboratory systems automation operating budgets and strategic capital projects.

• Partner with Manufacturing Quality Assurance Analytical Development Technical Operations Supply Chain Regulatory Procurement and external testing laboratories to support technology transfers product introductions supplier material qualification reduced-testing programs comparability investigations release and supply continuity.

• Make timely risk-based decisions within delegated authority for staffing laboratory priorities resource allocation budgets external testing quality events and operational recovery; escalate significant quality compliance safety or supply risks appropriately.

• Serve as the senior QC representative during health authority inspections internal audits governance forums and escalations; maintain sustained inspection readiness and ensure commitments are completed effectively and on time.

Qualifications & Experience:

• Bachelors degree in biology biochemistry microbiology chemistry biotechnology engineering or a related scientific discipline required; advanced degree preferred.

• Minimum of 10 years of relevant progressive experience in the pharmaceutical biotechnology or biopharmaceutical industry with substantial experience in GMP Quality Control laboratories.

• Minimum of five years of direct people-management experience with demonstrated success leading large complex organizations through multiple layers of leadership; experience with organizations comparable to 80 employees and contractors strongly preferred.

• Strong experience supporting biologics or biotherapeutics; direct experience with advanced therapies particularly cell and gene therapy testing is strongly preferred.

• Broad knowledge of analytical and microbiological laboratory operations analytical method lifecycle activities laboratory investigations data review statistical trending electronic laboratory systems sample management and equipment lifecycle management.

• Strong working knowledge of applicable FDA EMA ICH pharmacopeial and global cGMP expectations for biologics and advanced therapy products.

• Proven success managing multi-site operations operating and capital budgets laboratory capacity competing priorities organizational change and complex cross-functional initiatives.

• Excellent judgment communication influence problem-solving and stakeholder-management skills with the ability to make timely risk-based decisions in a complex regulated environment.

Travel & Working Conditions: This role requires periodic travel between Malvern and Spring House and may require approximately 1020% domestic or international travel. The incumbent must be able to work in laboratory and manufacturing environments and comply with applicable gowning personal protective equipment health safety and site-access requirements.

Key Competencies:

• Enterprise People Leadership: Builds leadership depth develops technical talent sets clear accountability and engages a large diverse workforce across two sites.

• QC Technical Acumen: Applies strong scientific and laboratory knowledge to biologics and cell and gene therapy testing strategies risks and decisions.

• Quality & Compliance Leadership: Maintains high standards for cGMP compliance data integrity documentation investigation quality and inspection readiness.

• Strategic & Operational Excellence: Converts portfolio and supply needs into practical capacity resource technology and improvement plans.

• Risk-Based Decision-Making: Integrates science compliance product knowledge and business context to resolve complex issues and escalate appropriately.

• Collaboration & Influence: Aligns stakeholders across sites and functions and communicates complex topics clearly to technical quality and senior leadership audiences.

Leadership Expectations:

• Model visible inclusive and accountable leadership across Malvern and Spring House.

• Ensure patient safety product quality compliance and employee safety remain central to all decisions.

• Set clear priorities remove barriers and hold leaders and teams accountable for sustainable results.

• Develop successors strengthen technical capability and provide timely coaching and performance feedback.

• Champion science- and risk-based improvement digital enablement standardization and collaboration while upholding J&J Credo values and respect for people.

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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Manager