Product Quality Lead

1 day ago


Devens, Massachusetts, United States Bristol-Myers Squibb Full time
Transforming Patients' Lives through Science

Bristol-Myers Squibb is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients overcome life-threatening diseases. We are seeking a highly skilled and experienced Product Quality Lead to join our team in Seattle, WA.

About the Role

The Product Quality Lead will be responsible for providing global product quality oversight and support for external manufacturing/partnerships and internal manufacturing operations. This includes developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.

Key Responsibilities
  • Provides global product quality oversight and support for external manufacturing/partnerships and internal manufacturing operations.
  • Develops and maintains relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
  • Supports the overall product quality strategy based on CMC/TCT deliverables, PD team objectives, life-cycle improvements, and regulatory commitments.
  • Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of clinical development efforts and life-cycle management activities.
  • Reviews clinical and commercial regulatory filings as needed.
Requirements
  • BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization.
  • Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle.
  • Experience with review of market applications, IND, supplements, or similar regulatory documentation.
  • Demonstrated technical skillset with analytics and/or process development.
  • Demonstrated ability in decision making and problem solving.
  • Demonstrated Quality leadership through partnership in a matrixed-organization.
What We Offer

Bristol-Myers Squibb offers a competitive compensation package, including a starting salary range of $166,000-$208,000, plus incentive cash and stock opportunities (based on eligibility). We also offer a comprehensive benefits package, including medical, pharmacy, dental, and vision care, as well as wellbeing support, financial well-being resources, and work-life programs.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about transforming patients' lives through science, we encourage you to apply for this exciting opportunity.



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