Senior Manager, Quality Control (Biologics and Advanced Therapies)

Location: Malvern, Pennsylvania (primary) and Spring House, Pennsylvania (secondary), United States; periodic travel between sites and approximately 10–20% domestic or international travel required.

Company

Johnson & Johnson develops healthcare solutions and medicines through its Innovative Medicine and MedTech businesses.

What you will do

• Lead and develop a multi-site Quality Control organization of more than 80 employees and contractors.
• Oversee QC laboratories supporting biotherapeutics, cell and gene therapy, clinical products, and commercial products.
• Manage sampling, testing, data review, release, stability, environmental monitoring, laboratory inventory, equipment, and analytical platforms.
• Direct investigations, CAPAs, change controls, method transfers, qualifications, validations, and inspection-readiness activities.
• Set laboratory capacity, staffing, contractor, budget, digital-system, automation, and capital-project strategies.
• Partner with Manufacturing, Quality Assurance, Analytical Development, Technical Operations, Supply Chain, Regulatory, Procurement, and external laboratories.

Requirements

• Bachelor’s degree in biology, biochemistry, microbiology, chemistry, biotechnology, engineering, or a related scientific discipline.
• At least 10 years of progressive experience in pharmaceutical, biotechnology, or biopharmaceutical Quality Control.
• At least five years of direct people-management experience leading large, complex organizations.
• Experience with GMP QC laboratories, biologics or biotherapeutics, analytical and microbiological operations, laboratory investigations, data review, and electronic laboratory systems.
• Working knowledge of FDA, EMA, ICH, pharmacopeial, and global cGMP expectations.
• Ability to work in laboratory and manufacturing environments and comply with gowning, PPE, health, safety, and site-access requirements.

Nice to have

• Advanced scientific degree.
• Direct experience with advanced therapies, particularly cell and gene therapy testing.
• Experience managing organizations comparable to 80 or more employees and contractors.

Culture & Benefits

• Inclusive and accountable leadership culture guided by the J&J Credo.
• Focus on patient safety, product quality, employee safety, technical excellence, and continuous improvement.
• Opportunity to develop leaders, strengthen technical capability, and build succession plans.
• Cross-functional and multi-site collaboration across quality, manufacturing, regulatory, supply, and technical teams.