The Senior Manager has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecule products
Job Summary
The Senior Manager has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecule products.
Johnson & Johnson provides an inclusive work environment respecting diversity and dignity, empowering employees' physical, mental, emotional, and financial health.
This role involves representing Global Quality on multiple teams, supporting audits, managing quality complaints, and driving decision making to ensure compliant quality strategies.
Matching Summary
The Senior Manager has end-to-end accountability for the quality strategy and quality aspects from Early Development through commercialization in Launch and Grow for an assigned group of large molecule products.
Skills & Requirements
Must-have
Quality strategy and compliance management
Global Quality liaison and communication
Health authority submission review and approval
Quality assurance in biotherapeutics manufacturing
Risk assessment and problem solving
Cross-functional team leadership
cGMP standards knowledge
Nice-to-have
Mentorship and collaboration skills
Experience with technology transfer and process validation
Knowledge of biotech and vaccine manufacturing
Flexible scheduling for global teams
Tactical thinking and technical credibility
Quality complaint trend analysis
Regulatory filing content development
Key Requirements
Bachelor’s degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering or similar
Minimum 8 years pharmaceutical or biotechnology industry experience
Knowledge of cGMP standards, policies and procedures