Vice President, Cell Therapy Global Quality
Bristol Myers Squibb
19 days ago
Remote friendly (Madison, NJ)
United States
Operations
Position Summary
Vice President, Cell Therapy Global Quality: Accountable for development, deployment, and execution of the Cell Therapy Quality strategy across Cell Therapy Development and Operations, building and optimizing the global quality organization (Patient Operations Quality, Internal/External Manufacturing & Supply Chain Quality, Global Product Quality incl. Development, Product Lifecycle & CMC Quality, Analytical Science & Technology, Quality Systems & Compliance).
Key Responsibilities
- Lead global quality and compliance leadership for site/above-site professionals across assigned locations; provide end-to-end quality oversight for development, clinical manufacturing, and commercial manufacturing.
- Set quality/compliance standards and drive adherence to cGMP and company policies; oversee complex investigations and evolving global regulations.
- Lead governance/accountability: leadership team management reviews/annual product reviews/audits & inspections/data integrity/GMP health authority reporting; Tier 1/2 Quality Council metrics.
- Own product quality lifecycle management and BLA approval/enabling activities (CMC documentation, pre-license inspection readiness).
- Develop/deploy global quality processes and systems for commercialization; set goals/metrics; ensure quality decisions and harmonization/continuous improvement.
- Oversee health authority audits/inspections; lead across a matrix and partner with Global Quality, Legal, leadership, Operations, Supply Chain, Regulatory, Clinical, MSAT, Development, and Finance.
- Drive technology and IT-enabled quality improvements; sponsor cross-functional projects; lead budgeting and workforce staffing; succession planning; mentor/coaching.
Qualifications & Experience
- BS in relevant Science/Engineering; MBA/MS/PhD preferred.
- 20+ years quality leadership (site and above-site); strong bio/pharma commercial manufacturing and people leadership.
- Required: Biologics or Cell/Gene Therapy manufacturing experience.
- GxP expertise; health authority inspection experience; deep global regulatory knowledge.
- Proficient in quality management systems and biopharmaceutical manufacturing technologies; interpret complex data.
- Leadership across multi-product plants and large matrix teams; strong communication, talent development, succession planning, and financial acumen.
Compensation (explicit)
- $381,440 - $462,213 (starting range); additional incentive cash/stock may be available.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k) and insurance/disability/life; paid time off (flexible/unlimited for some; specific vacation/holidays for others) and additional time off based on eligibility.
On-site Protocol (role-specific)
- Site-essential: 100% onsite; Site-by-design: hybrid with at least 50% onsite; Field/remote-by-design: ability to travel as directed.
Vice President, Cell Therapy Global Quality: Accountable for development, deployment, and execution of the Cell Therapy Quality strategy across Cell Therapy Development and Operations, building and optimizing the global quality organization (Patient Operations Quality, Internal/External Manufacturing & Supply Chain Quality, Global Product Quality incl. Development, Product Lifecycle & CMC Quality, Analytical Science & Technology, Quality Systems & Compliance).
Key Responsibilities
- Lead global quality and compliance leadership for site/above-site professionals across assigned locations; provide end-to-end quality oversight for development, clinical manufacturing, and commercial manufacturing.
- Set quality/compliance standards and drive adherence to cGMP and company policies; oversee complex investigations and evolving global regulations.
- Lead governance/accountability: leadership team management reviews/annual product reviews/audits & inspections/data integrity/GMP health authority reporting; Tier 1/2 Quality Council metrics.
- Own product quality lifecycle management and BLA approval/enabling activities (CMC documentation, pre-license inspection readiness).
- Develop/deploy global quality processes and systems for commercialization; set goals/metrics; ensure quality decisions and harmonization/continuous improvement.
- Oversee health authority audits/inspections; lead across a matrix and partner with Global Quality, Legal, leadership, Operations, Supply Chain, Regulatory, Clinical, MSAT, Development, and Finance.
- Drive technology and IT-enabled quality improvements; sponsor cross-functional projects; lead budgeting and workforce staffing; succession planning; mentor/coaching.
Qualifications & Experience
- BS in relevant Science/Engineering; MBA/MS/PhD preferred.
- 20+ years quality leadership (site and above-site); strong bio/pharma commercial manufacturing and people leadership.
- Required: Biologics or Cell/Gene Therapy manufacturing experience.
- GxP expertise; health authority inspection experience; deep global regulatory knowledge.
- Proficient in quality management systems and biopharmaceutical manufacturing technologies; interpret complex data.
- Leadership across multi-product plants and large matrix teams; strong communication, talent development, succession planning, and financial acumen.
Compensation (explicit)
- $381,440 - $462,213 (starting range); additional incentive cash/stock may be available.
Benefits (explicit)
- Health coverage; wellbeing support; 401(k) and insurance/disability/life; paid time off (flexible/unlimited for some; specific vacation/holidays for others) and additional time off based on eligibility.
On-site Protocol (role-specific)
- Site-essential: 100% onsite; Site-by-design: hybrid with at least 50% onsite; Field/remote-by-design: ability to travel as directed.