Senior Manager Quality Strategy (Biologics/Cell Therapy)

Location: Raritan, New Jersey, United States of America; onsite role

Base pay: $122,000–$212,750 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, including advanced therapies and related manufacturing operations.

What you will do

• Lead the development, governance, and execution of the Raritan Quality strategic portfolio across Quality Assurance, Quality Control, and Quality Systems.
• Drive quality improvement initiatives, digital capabilities, quality system implementations, and scalable compliant processes across the Advanced Therapies network.
• Partner with site, platform, enterprise, and cross-functional stakeholders to improve productivity, compliance, turnaround time, cost efficiency, and operational performance.
• Coordinate long-range financial planning, CAPEX and OPEX priorities, capability needs, and resource alignment.
• Monitor Cell and Gene Therapy quality forums, regulatory trends, industry standards, and inspection-readiness requirements.
• Lead strategic communications and department operating rhythms, including leadership meetings, decisions, action tracking, and organizational planning.

Requirements

• At least 8 years of experience in Quality Assurance, Quality Systems, Quality Control, Operations, or manufacturing in a regulated environment.
• Experience implementing and overseeing GMP operations in a commercial manufacturing facility.
• Knowledge of FDA and EU cGMP regulations and guidance.
• Strong understanding of quality organization models, governance, risk-based decision-making, budgeting, CAPEX, OPEX, and workforce planning.
• Experience leading business improvement initiatives and influencing stakeholders in a global matrix environment.
• Fluent written and verbal English communication skills are required. A bachelor’s degree in engineering, science, business, or an equivalent discipline is strongly preferred.

Nice to have

• Experience in biologics and/or cell therapy.
• Experience with Process Excellence, Design Excellence, Lean, or Six Sigma.
• Working knowledge of TComet and truVault quality system applications.
• Additional language skills.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Participation in a consolidated retirement plan and 401(k) savings plan.
• Vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time-off.
• Inclusive interview accommodations are available for applicants with disabilities.