At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Duties/Responsibilities
- ✓The AQA Manager will provide QA review and approval of technical documents and Quality Management System (QMS) records pertaining to Commercial GMP analytical methods for biologics and small molecules drug substances and drug products.
- ✓The scope of documents will range from Commercial method validation throughout the product lifecycle of methods.
- ✓Perform the QA review/approval of GMP documentation, including but not limited to:
- ✓Analytical method validation and transfer for release and stability testing
- ✓Analytical method procedures and associated change controls
- ✓Protocols, reports and CoAs for analytical reference material and critical reagents
- ✓Procedural and supporting documents
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- ✓Collaborate with the relevant analytical and operational functions to determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related to qualification of analytical methods or reference standards
- ✓o Communicate, share, and escalate issues within the AQA team for consensus resolution when appropriate
- ✓Perform Quality approval of various QMS records, including change control management, CAPAs, standalone actions, effectiveness checks
- ✓Assist in the development and implementation of continuous improvement initiatives for Quality and QC functions
Qualifications required
- ✓Minimum of 5 years professional experience in Biologics and/or Small Molecule Quality Assurance, Quality Control, analytical chemistry, method development is desirable
- ✓Previous experience in QC laboratory-facing QA activities is highly desirable
- ✓Previous experience using electronic document and quality management systems (i.e. DCA, Veeva, PDLIMS, Trackwise) is required.
- ✓Working knowledge of QC, QA, analytical method development or method validation functions
- ✓Understanding and knowledge of FDA guidelines and GxP regulations.
- ✓Excellent communication, attention to detail, relationship management, negotiation, problem-solving and personal time management skills
- ✓Ability to manage multiple priorities with aggressive timelines
#LI-Hybrid
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
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