Senior Director, Product Quality Engineering
Bristol Myers Squibb
5 days ago
Remote friendly (Devens, MA)
United States
Operations
Position Summary
- Senior Director of Cell Therapy Product Quality Engineering leads a global team ensuring cGMP compliance, product quality, and regulatory readiness for BMS.
- Accountable for global standardization and harmonization of product quality principles, processes, and governance across the cell therapy portfolio.
- Partners in a matrix environment with Global Product Quality Leads and functional leaders to ensure consistent application of GPQ standards, risk frameworks, and lifecycle strategies.
Key Responsibilities
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across sites/programs.
- Lead a global matrix team of product quality experts to achieve alignment across products.
- Drive lifecycle platform strategies for Integrated Control Strategy (ICS), Stability, analytical lifecycle management, jurisdictional control, and specification strategy.
- Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics.
- Ensure harmonized processes meet global regulatory requirements and support inspection readiness.
- Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into workflows.
- Foster innovation, agility, collaboration, inclusion, and a compliance/quality mindset.
- Establish and meet quality performance and compliance metrics aligned with business/financial objectives.
- Lead internal/external governance meetings (steering committees, partner collaborations) for proactive quality management.
Basic Qualifications
- BS/MS/PhD in Life Sciences (Biology, Chemistry, Engineering) or related field; 12–15+ years GMP Quality; 7+ years people management; 5+ years in cell therapy/gene therapy/advanced biologics manufacturing.
- Experience leading global quality teams in a matrix environment; hiring/coaching/developing technical talent.
- Deep cGMP, regulatory, and quality system knowledge for cell and gene therapy manufacturing.
- Strategic, analytical problem-solving and decision-making skills.
- Strong written/verbal communication across all organizational levels and with external partners.
- Experience with technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
- Ability to work in a fast-paced environment with robust compliance/quality oversight.
- Experience driving continuous improvement and business process digitization within quality operations.
Preferred Qualifications
- Experience with autologous CAR T, viral vector manufacturing, and quality control equipment/system automation.
- Product Quality Leadership for cell/gene therapy.
- Track record supporting product launches, BLA submissions, and regulatory interactions.
- Combination of quality assurance, quality control, and compliance across process development, MS&T, and external manufacturing.
- Senior Director of Cell Therapy Product Quality Engineering leads a global team ensuring cGMP compliance, product quality, and regulatory readiness for BMS.
- Accountable for global standardization and harmonization of product quality principles, processes, and governance across the cell therapy portfolio.
- Partners in a matrix environment with Global Product Quality Leads and functional leaders to ensure consistent application of GPQ standards, risk frameworks, and lifecycle strategies.
Key Responsibilities
- Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across sites/programs.
- Lead a global matrix team of product quality experts to achieve alignment across products.
- Drive lifecycle platform strategies for Integrated Control Strategy (ICS), Stability, analytical lifecycle management, jurisdictional control, and specification strategy.
- Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics.
- Ensure harmonized processes meet global regulatory requirements and support inspection readiness.
- Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into workflows.
- Foster innovation, agility, collaboration, inclusion, and a compliance/quality mindset.
- Establish and meet quality performance and compliance metrics aligned with business/financial objectives.
- Lead internal/external governance meetings (steering committees, partner collaborations) for proactive quality management.
Basic Qualifications
- BS/MS/PhD in Life Sciences (Biology, Chemistry, Engineering) or related field; 12–15+ years GMP Quality; 7+ years people management; 5+ years in cell therapy/gene therapy/advanced biologics manufacturing.
- Experience leading global quality teams in a matrix environment; hiring/coaching/developing technical talent.
- Deep cGMP, regulatory, and quality system knowledge for cell and gene therapy manufacturing.
- Strategic, analytical problem-solving and decision-making skills.
- Strong written/verbal communication across all organizational levels and with external partners.
- Experience with technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
- Ability to work in a fast-paced environment with robust compliance/quality oversight.
- Experience driving continuous improvement and business process digitization within quality operations.
Preferred Qualifications
- Experience with autologous CAR T, viral vector manufacturing, and quality control equipment/system automation.
- Product Quality Leadership for cell/gene therapy.
- Track record supporting product launches, BLA submissions, and regulatory interactions.
- Combination of quality assurance, quality control, and compliance across process development, MS&T, and external manufacturing.