CSV Cell Therapy Manager — Validation & Compliance

Biopharma Careers; Summit West (CA); On-site; USD 107,000 - 129,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) Plan

Paid Time Off

Job summary

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to lead qualification/validation of equipment and computerized systems across multi-use sites. You will supervise projects, ensure compliance with cGXP and CFR 21 Part 11, and drive timely completion while fostering collaboration with manufacturing, QA and facilities teams.

The role emphasizes hands-on leadership, cross-functional support, and the development of quality procedures and training materials to sustain validated operations.

Qualifications

• BS degree or equivalent experience.
• Minimum 5 years in FDA-regulated industry.
• Excellent understanding of cGXP and documentation practices.
• Strong knowledge of 21 CFR Part 11 compliance.
• Experience with equipment qualification documents.
• Ability to interact with manufacturing, laboratory, QA and Facilities.

Responsibilities

• Maintains qualified/validated equipment and systems per policies and procedures.
• Investigates deviations and CAPA; documents validation activities.
• Configures computerized systems to CFR21 Part 11 requirements.
• Leads qualification/validation deliverables and vendors.
• Owns lifecycle deliverables for equipment qualification and CSV.
• Develops validation plans, requirements, protocols, traceability matrices, change controls.

Education

BS degree or equivalent experience

Job description

Bristol Myers Squibb is seeking a Manager, CSV Cell Therapy to lead qualification/validation of equipment and computerized systems across multi-use sites. You will supervise projects, ensure compliance with cGXP and CFR 21 Part 11, and drive timely completion while fostering collaboration with manufacturing, QA and facilities teams.

The role emphasizes hands-on leadership, cross-functional support, and the development of quality procedures and training materials to sustain validated operations.