Vice President, GBU Quality
Bristol Myers Squibb
5 hours ago
Remote friendly (Princeton, NJ)
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 high cGMP compliance and the safety, efficacy, and quality of all 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 overall GBU Network Strategy and operational performance.
- Part of the Global Quality Leadership Team (GQLT) and the GBU Leadership Team; manage a team of managers (including Site Quality Heads and other Quality Leaders) and collaborate with Global Manufacturing and Supply Chain.
Key Responsibilities
- Support development, direction, and execution of GBU (Biologics & Pharma) manufacturing quality strategy.
- Provide leadership for a multi-functional group of quality professionals to achieve a uniform quality strategy aligned to market practices and regulatory trends.
- Ensure a robust quality management system is implemented to achieve GBU manufacturing quality objectives.
- Participate in required quality management reviews to progress the suitability/effectiveness of the quality management system and GMP compliance.
- Deploy Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk.
- Manage/support resolution of quality and technical problems (internal and external manufacturing) per global standards.
- Support audits and Health Authority inspections; assist with HA responses and CAPAs; escalate critical/major issues affecting product quality or supply risk and resolve within timelines.
- Assure 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 QMS.
- Provide quality oversight and appropriate resourcing for complex projects (transfers, launches, due diligence, etc.) to ensure QMS compliance and enable escalation/resolution.
- Coordinate/provide SME input to BMS policies, directives, and SOPs related to quality compliance.
- Lead communications and develop strategies/partnerships with stakeholders across Manufacturing, SB&E, Supply Chain, Regulatory, Project Management, and Operations.
- Recruit and develop global talent; build a high-performance culture and succession planning.
- Coach/lead/mentor direct reports and develop a capable quality team.
- Support deployment of operational excellence strategies within Quality GBU Manufacturing.
- Prepare and manage the Quality GBU organizational budget.
- Champion development and implementation of innovative and digital solutions across the GBU Quality team.
Qualifications & Experience
- B.S. in relevant Science or Engineering; advanced degree preferred (MBA, MS, or PhD).
- 20+ years of experience managing quality and compliance organizations.
- Proficiency in quality compliance processes and regulations (e.g., cGMP/GDP for External Manufacturing QA).
- Thorough understanding of company policies and regulatory requirements and how they relate to management/documentation of product quality investigations.
- Thorough understanding of technical areas related to pharmaceutical/biological manufacturing, chemical/biochemical analyses, microbiological analyses, statistical methods, and regulatory/quality control/quality assurance processes.
- Excellent communication and interpersonal skills; able to interface with broad internal/external stakeholders.
- Proven record delivering results; action oriented; experience with compliance remediation due to regulatory actions.
- Strategic thinker with high business acumen and enterprise-wide decision making.
- Excellent influencing/negotiation experience in a matrix environment; credible senior-leader interface.
- Sound judgment based on gathered/analyzed information.
- Ability to build trusting relationships, lead large/complex programs, and work across divisions, cultures, and backgrounds.
- High performance standards and strong attention to detail.
- Ability to adapt to changing priorities and environments; plan/organize/schedule work to meet objectives.
- Demonstrates enterprise advocacy, tradeoff evaluation, and drives bold decisions aligned with patients and the organization.
Required/Preferred Skills (from competencies)
- Quality compliance leadership; GMP/GDP knowledge.
- Quality risk management.
- Audit/inspection and CAPA governance.
- Stakeholder management and cross-functional leadership.
- Talent development and leadership in a matrix environment.
- Innovative/digital solution adoption.
Compensation & Benefits (explicitly stated)
- Base compensation range: $333,760 - $404,440.
- Additional incentive cash and stock opportunities may be available (eligibility-based).
- Health coverage; wellbeing support programs; financial wellbeing/protection (401(k), disability, life insurance, etc.); Paid Time Off (details vary by employee type/location).
- 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 high cGMP compliance and the safety, efficacy, and quality of all 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 overall GBU Network Strategy and operational performance.
- Part of the Global Quality Leadership Team (GQLT) and the GBU Leadership Team; manage a team of managers (including Site Quality Heads and other Quality Leaders) and collaborate with Global Manufacturing and Supply Chain.
Key Responsibilities
- Support development, direction, and execution of GBU (Biologics & Pharma) manufacturing quality strategy.
- Provide leadership for a multi-functional group of quality professionals to achieve a uniform quality strategy aligned to market practices and regulatory trends.
- Ensure a robust quality management system is implemented to achieve GBU manufacturing quality objectives.
- Participate in required quality management reviews to progress the suitability/effectiveness of the quality management system and GMP compliance.
- Deploy Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk.
- Manage/support resolution of quality and technical problems (internal and external manufacturing) per global standards.
- Support audits and Health Authority inspections; assist with HA responses and CAPAs; escalate critical/major issues affecting product quality or supply risk and resolve within timelines.
- Assure 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 QMS.
- Provide quality oversight and appropriate resourcing for complex projects (transfers, launches, due diligence, etc.) to ensure QMS compliance and enable escalation/resolution.
- Coordinate/provide SME input to BMS policies, directives, and SOPs related to quality compliance.
- Lead communications and develop strategies/partnerships with stakeholders across Manufacturing, SB&E, Supply Chain, Regulatory, Project Management, and Operations.
- Recruit and develop global talent; build a high-performance culture and succession planning.
- Coach/lead/mentor direct reports and develop a capable quality team.
- Support deployment of operational excellence strategies within Quality GBU Manufacturing.
- Prepare and manage the Quality GBU organizational budget.
- Champion development and implementation of innovative and digital solutions across the GBU Quality team.
Qualifications & Experience
- B.S. in relevant Science or Engineering; advanced degree preferred (MBA, MS, or PhD).
- 20+ years of experience managing quality and compliance organizations.
- Proficiency in quality compliance processes and regulations (e.g., cGMP/GDP for External Manufacturing QA).
- Thorough understanding of company policies and regulatory requirements and how they relate to management/documentation of product quality investigations.
- Thorough understanding of technical areas related to pharmaceutical/biological manufacturing, chemical/biochemical analyses, microbiological analyses, statistical methods, and regulatory/quality control/quality assurance processes.
- Excellent communication and interpersonal skills; able to interface with broad internal/external stakeholders.
- Proven record delivering results; action oriented; experience with compliance remediation due to regulatory actions.
- Strategic thinker with high business acumen and enterprise-wide decision making.
- Excellent influencing/negotiation experience in a matrix environment; credible senior-leader interface.
- Sound judgment based on gathered/analyzed information.
- Ability to build trusting relationships, lead large/complex programs, and work across divisions, cultures, and backgrounds.
- High performance standards and strong attention to detail.
- Ability to adapt to changing priorities and environments; plan/organize/schedule work to meet objectives.
- Demonstrates enterprise advocacy, tradeoff evaluation, and drives bold decisions aligned with patients and the organization.
Required/Preferred Skills (from competencies)
- Quality compliance leadership; GMP/GDP knowledge.
- Quality risk management.
- Audit/inspection and CAPA governance.
- Stakeholder management and cross-functional leadership.
- Talent development and leadership in a matrix environment.
- Innovative/digital solution adoption.
Compensation & Benefits (explicitly stated)
- Base compensation range: $333,760 - $404,440.
- Additional incentive cash and stock opportunities may be available (eligibility-based).
- Health coverage; wellbeing support programs; financial wellbeing/protection (401(k), disability, life insurance, etc.); Paid Time Off (details vary by employee type/location).