Senior Manager, Sterility Assurance - Summit, NJ

Senior Manager, Sterility Assurance - Summit, NJ

Position Summary:

The Sr. Manager, Sterility Assurance is a highly critical role responsible for managing Sterility Assurance for the CAR T manufacturing site. Supports facility design/modifications, aseptic process validation program, operator qualification, gowning certification program, critical utilities sampling and testing, and overall contamination control program. Acts as SME during regulatory inspections.

• Support final product testing and release, incoming components and materials testing and release and monitoring of critical utilities systems.
• Develop and manage SOPs, forms, and methods required to support compliant operation.
• Ensure execution and support of contamination control strategy for the facility including aseptic process validation, facility design and modification, gowning, critical utilities, and EMPQs.
• Generate, own, and support change controls, deviations, CAPAs within eQMS system.
• Support equipment, facility, and microbiological method qualifications.
• Ensure site and department objectives are met.
• Manage and develop direct reports.
• Onboard new materials required to support manufacturing operations.
• Support manufacturing schedule and needs.
• Ensure employees are properly trained and qualified, provide performance evaluations, support career development of direct reports.
• Gown for entry into aseptic core and supporting areas as needed.
• On call to support manufacturing issues involving sampling and testing during shift operations.
• Occasional travel may be required.

• Advanced knowledge of cGMPs, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines related to manufacture of cell therapy products.
• Advanced data integrity knowledge and practices.
• Intermediate understanding of statistics, control charts, action and alert limits and data trending.
• Advanced knowledge of Microbiology.
• Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs.
• Advanced verbal and written communication skills.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Team-oriented, cross‑departmentally collaborative across manufacturing site.
• Leadership and management skills: establishing direction and goals, guiding execution, fostering team environment.
• Advanced mentoring and coaching, influencing, negotiating, personal interaction skills.
• Resource management and planning skills.
• Flexible and adaptable, work under pressure, meet timelines.
• Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment, lockout/tagout, fall safety, HAZCOM, MSDS sheets.
• Advanced Microsoft Word, Outlook, Excel, PowerPoint.
• Microbiology laboratory and/or Environmental Monitoring setting.

• 2‑3 years of leadership/managerial experience required.
• Experience in participating and supporting regulatory audits preferred: FDA, MHRA, PMDA, etc.
• Experience in working with Quality Systems preferred: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments.
• Experience in working with cell therapy products is preferred.
• An equivalent combination of education and experience may substitute.

Summit West - NJ - US: $121,070 - $,703. Additional incentive cash and stock opportunities may be available.

Job Code:
Pharmaceutical Pharmaceutical. Affiliate Sponsor:
Bristol Myers Squibb.