Sr Manager, Sterility Assurance - Summit West NJ

About the role

The Sr. Manager, Sterility Assurance is a critical role responsible for managing Sterility Assurance at the CAR T manufacturing site. Key responsibilities include supporting final product testing and release, incoming components and materials testing and release, monitoring critical utilities systems, developing SOPs, and ensuring compliance with cGMPs and other relevant regulations.

Responsibilities

• Support final product testing and release, incoming components and materials testing and release and monitoring of the critical utilities systems.
• Development and management of SOPs, forms, and methods required to support the compliant operation.
• Generate, own, and/or support change controls, deviations, CAPAs within the eQMS system.
• Support Equipment, Facility, And Microbiological Method Qualifications.
• Ensure the 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 to perform assigned tasks, provide performance evaluations, and support career development of direct reports.
• Must gown for entry into Aseptic core and supporting areas, on an as-needed basis.
• Manage manufacturing issues involving sampling and/or test excursions or questions during shift operations.

Qualifications

• Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as 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, etc.
• Advanced verbal and written communication skills.
• Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills.
• Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site.
• Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
• Advanced mentoring and coaching, influencing, negotiating and personal interaction skills.
• Demonstrated resource management and planning skills.
• Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.
• Advanced knowledge of safety, OSHA, and EPA regulations, electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
• Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc.
• Microbiology laboratory and/or Environmental Monitoring setting experience preferred.
• Experience Working With Cell Therapy Products is preferred.
• 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.

Benefits

Summit West offers competitive compensation and benefits, including a comprehensive health plan, retirement savings options, and opportunities for professional growth and development.

Pay

$121,070 - $146,703

Schedule

Full-time