Vice President, GBU Quality
Bristol Myers Squibb
5 hours ago
Remote friendly (Devens, MA)
United States
Operations
Position Summary
- In support of the Chief Quality Officer, define and shape the Quality strategy for the Global Business Unit (GBU) Manufacturing Quality Network (biologics & pharma operating units, internal and external) to ensure cGMP compliance and the safety, efficacy, and quality of bio/pharma commercial products.
- Direct quality operations teams supporting manufacturing, laboratory operations, and releasing/certifying products (internal and external manufacturing).
- Ensure consistency and alignment with the GBU Network Strategy and operational performance; member of the Global Quality Leadership Team (GQLT) and GBU Leadership Team.
- Manage managers, including Site Quality Heads and other Quality Leaders; collaborate with Global Manufacturing and Supply Chain.
Key Responsibilities
- Support development, direction, and execution of GBU (Biologics & Pharma) manufacturing quality strategy.
- Lead a multi-functional group of quality professionals to achieve a uniform quality strategy aligned to regulatory trends.
- Implement and maintain a robust quality management system per global standards to achieve GBU quality objectives.
- Improve suitability/effectiveness of the quality management system and GMP compliance via required quality management reviews.
- Deploy Quality Risk Management for quality oversight and problem resolution to mitigate risk.
- Manage/support resolution of quality and technical problems across internal and external manufacturing.
- Support audits and Health Authority inspections; assist with HA responses and CAPAs; ensure escalation of critical/major issues and resolution within timelines.
- Provide quality governance via management reviews of quality KPIs/metrics, process performance indicators, quality system signals, and supply risks; initiate corrective actions and follow up.
- Ensure GMP follow-up actions for audit/inspection observations are tracked and actioned per the QMS.
- Provide quality oversight and resourcing for complex projects (transfers, launches, due-diligence, etc.) to ensure QMS compliance and support escalation/resolution.
- Coordinate/provide SME input to BMS policies, directives, and SOPs related to quality compliance.
- Lead communication and develop strategies/partnerships with stakeholders across Manufacturing, SB&E, Supply Chain, Regulatory, Project Management, and Operations.
- Recruit, develop, mentor, and coach global talent; build high-performance culture; develop succession potential.
- Support deployment of operational excellence strategies within Quality GBU Manufacturing.
- Prepare and manage the Quality GBU organizational budget.
- Champion innovative and digital solutions across the GBU Quality team and organization.
Qualifications & Experience
- B.S. in relevant Science or Engineering; advanced degree preferred (MBA, MS, PhD).
- 20+ years managing quality and compliance organizations.
- Proficiency in quality compliance processes and regulations (e.g., cGMP/GDP for External Manufacturing QA).
- Strong understanding of company policies and regulatory requirements and how they relate to product quality investigations.
- Thorough technical understanding of pharmaceutical/biological manufacturing and related analyses (chemical/biochemical, microbiological, statistical methods), and regulatory/QC/QA processes.
- Excellent communication and interpersonal skills with broad stakeholder interface.
- Proven results delivery; action-oriented; experience with compliance remediation tied to regulatory actions.
- Strategic, high business acumen; strong influencing/negotiating in matrix environments; credible leader able to interface with senior leaders.
- Sound judgment based on analyzed information; ability to build relationships and lead large/complex programs across divisions and cultures.
- Maintain high performance standards and attention to detail; adapt to changing priorities; plan/organize tasks to meet objectives.
Preferred/Behavioral (as stated)
- Enterprise advocate who evaluates tradeoffs for BMS/patient best interest; embraces complexity while striving for simplicity.
- External mastery; change-activator mindset; courageous innovator; authentic leadership; proactive talent development.
Compensation / Benefits (explicitly stated)
- Compensation: $333,760 - $404,440 (full-time). Additional incentive cash/stock may be available based on eligibility.
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (EAP and others); financial protection (401(k), disability, life insurance, etc.); paid time off (flexible time off and national holidays; details vary by location/role type).
Application Instructions
- If the posting is missing required local information or incorrect, contact TAEnablement@bms.com (include Job Title and requisition number).
- In support of the Chief Quality Officer, define and shape the Quality strategy for the Global Business Unit (GBU) Manufacturing Quality Network (biologics & pharma operating units, internal and external) to ensure cGMP compliance and the safety, efficacy, and quality of bio/pharma commercial products.
- Direct quality operations teams supporting manufacturing, laboratory operations, and releasing/certifying products (internal and external manufacturing).
- Ensure consistency and alignment with the GBU Network Strategy and operational performance; member of the Global Quality Leadership Team (GQLT) and GBU Leadership Team.
- Manage managers, including Site Quality Heads and other Quality Leaders; collaborate with Global Manufacturing and Supply Chain.
Key Responsibilities
- Support development, direction, and execution of GBU (Biologics & Pharma) manufacturing quality strategy.
- Lead a multi-functional group of quality professionals to achieve a uniform quality strategy aligned to regulatory trends.
- Implement and maintain a robust quality management system per global standards to achieve GBU quality objectives.
- Improve suitability/effectiveness of the quality management system and GMP compliance via required quality management reviews.
- Deploy Quality Risk Management for quality oversight and problem resolution to mitigate risk.
- Manage/support resolution of quality and technical problems across internal and external manufacturing.
- Support audits and Health Authority inspections; assist with HA responses and CAPAs; ensure escalation of critical/major issues and resolution within timelines.
- Provide quality governance via management reviews of quality KPIs/metrics, process performance indicators, quality system signals, and supply risks; initiate corrective actions and follow up.
- Ensure GMP follow-up actions for audit/inspection observations are tracked and actioned per the QMS.
- Provide quality oversight and resourcing for complex projects (transfers, launches, due-diligence, etc.) to ensure QMS compliance and support escalation/resolution.
- Coordinate/provide SME input to BMS policies, directives, and SOPs related to quality compliance.
- Lead communication and develop strategies/partnerships with stakeholders across Manufacturing, SB&E, Supply Chain, Regulatory, Project Management, and Operations.
- Recruit, develop, mentor, and coach global talent; build high-performance culture; develop succession potential.
- Support deployment of operational excellence strategies within Quality GBU Manufacturing.
- Prepare and manage the Quality GBU organizational budget.
- Champion innovative and digital solutions across the GBU Quality team and organization.
Qualifications & Experience
- B.S. in relevant Science or Engineering; advanced degree preferred (MBA, MS, PhD).
- 20+ years managing quality and compliance organizations.
- Proficiency in quality compliance processes and regulations (e.g., cGMP/GDP for External Manufacturing QA).
- Strong understanding of company policies and regulatory requirements and how they relate to product quality investigations.
- Thorough technical understanding of pharmaceutical/biological manufacturing and related analyses (chemical/biochemical, microbiological, statistical methods), and regulatory/QC/QA processes.
- Excellent communication and interpersonal skills with broad stakeholder interface.
- Proven results delivery; action-oriented; experience with compliance remediation tied to regulatory actions.
- Strategic, high business acumen; strong influencing/negotiating in matrix environments; credible leader able to interface with senior leaders.
- Sound judgment based on analyzed information; ability to build relationships and lead large/complex programs across divisions and cultures.
- Maintain high performance standards and attention to detail; adapt to changing priorities; plan/organize tasks to meet objectives.
Preferred/Behavioral (as stated)
- Enterprise advocate who evaluates tradeoffs for BMS/patient best interest; embraces complexity while striving for simplicity.
- External mastery; change-activator mindset; courageous innovator; authentic leadership; proactive talent development.
Compensation / Benefits (explicitly stated)
- Compensation: $333,760 - $404,440 (full-time). Additional incentive cash/stock may be available based on eligibility.
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (EAP and others); financial protection (401(k), disability, life insurance, etc.); paid time off (flexible time off and national holidays; details vary by location/role type).
Application Instructions
- If the posting is missing required local information or incorrect, contact TAEnablement@bms.com (include Job Title and requisition number).