Sr Manager Quality Control

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com.

About the role

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. The position is a member of the Site Quality Leadership Team, reports to the Site Quality Head, and leads an organization of 80+ full‑time employees and contractors.

Key Responsibilities

• Lead, develop, and retain a multi‑site QC organization of 80+ employees and contractors; set vision, organization design, operating model, goals, performance expectations, succession plans, and workforce strategy.
• Exercise leadership authority for talent acquisition, performance management, development, recognition, compensation recommendations, promotions, employee relations, organizational design, and corrective actions in partnership with Human Resources.
• Build a culture of quality, safety, accountability, inclusion, technical excellence, collaboration, and continuous improvement.
• Provide integrated oversight of QC testing laboratories supporting biotherapeutics and advanced therapies, ensuring 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.
• Oversee sample management, reference standards, critical reagents, laboratory inventory, and qualification, calibration, maintenance, and lifecycle management of QC equipment.
• Oversee lifecycle of analytical platforms and assays (identity, purity, potency, safety, microbiological, molecular, cell‑based, compendial) with appropriate controls for complex advanced therapy products.
• Ensure execution of method development support, qualification, validation, transfer, verification, and QC support for Process Performance Qualification, Continued Process Verification, and product comparability.
• Maintain laboratory compliance with cGMP requirements, global quality standards, approved procedures, data integrity principles, and health, safety, and environmental expectations.
• Govern and close non‑conformance investigations, invalid assays, out‑of‑specification and out‑of‑trend results, laboratory investigations, CAPAs, change controls, method transfers, qualifications, and validations.
• Maintain validated, reliable, inspection‑ready computerized laboratory systems (e.g., eLIMS, Empower) for sample, instrument, method, and data management.
• Provide accurate QC data and trend analyses for annual product reviews, quarterly management reviews, CPV, investigations, regulatory submissions, and product quality complaint assessments.
• Establish and monitor metrics for testing delivery, right‑first‑time performance, backlog, cycle time, capacity, compliance, and reliability; lead recovery and risk‑mitigation plans.
• Define and execute multi‑site QC strategy including capacity, headcount, contractor planning, scheduling, asset and facility needs, digital laboratory systems, automation, operating budgets, and strategic capital projects.
• Partner with Manufacturing, QA, Analytical Development, Technical Operations, Supply Chain, Regulatory, Procurement, and external labs to support technology transfers, product introductions, supplier 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 risks appropriately.
• Serve as 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

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or related scientific discipline (advanced degree preferred).
• Minimum 10 years of progressive experience in the pharmaceutical, biotechnology, or biopharmaceutical industry, with substantial experience in GMP Quality Control laboratories.