Bristol Myers Squibb

Senior Director, Product Quality Engineering

Bristol Myers Squibb

full-time

Posted on:

Location Type: Hybrid

Location: Seattle • Massachusetts • New Jersey • United States

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Salary

💰 $239,290 - $298,092 per year

Job Level

Senior

About the role

  • Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across all sites and programs.
  • Lead a global matrix team of product quality experts, influencing without direct authority 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 across programs.
  • Ensure all harmonized processes meet global regulatory requirements and support inspection readiness.
  • Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into operational workflows.
  • Foster a culture of innovation, agility, collaboration, and inclusion within the quality team, while maintaining a strong compliance and quality mindset.
  • Establish and meet ambitious quality performance and compliance metrics in alignment with business and financial objectives.
  • Lead internal and external governance meetings, including steering committees and partner collaborations, to ensure alignment and proactive quality management.

Requirements

  • BS, MS, or PhD in Life Sciences (Biology, Chemistry, Engineering) or related field with 12–15+ years of experience in GMP Quality, with 7+ years in people management, and 5+ years supporting cell therapy, gene therapy, or advanced biologics manufacturing.
  • Demonstrated experience leading global quality teams in a matrixed environment, with a track record of hiring, coaching, and developing technical talent.
  • Deep knowledge of cGMP compliance, regulatory requirements, and quality systems in cell and gene therapy manufacturing.
  • Strategic thinker with strong analytical, problem-solving, and decision-making skills.
  • Excellent written and verbal communication skills, with an ability to interact effectively at all levels of the organization and with external partners.
  • Experience supporting technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
  • Ability to work in a fast-paced environment, balancing agility with robust compliance and quality oversight.
  • Experience driving continuous improvement and supporting business process digitization within quality operations.
Benefits
  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
  • Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP QualitycGMP compliancequality systemsanalytical lifecycle managementproduct quality risk assessmentprocess qualificationcomparabilityvalidationtechnical transfersmanufacturing technologies
Soft Skills
leadershipanalytical skillsproblem-solvingdecision-makingcommunication skillscollaborationinnovationagilityinclusioncoaching