Manager, Analytical Quality Assurance

Bristol Myers Squibb

. Provide QA review and approval of technical documents and Quality Management System records for Commercial GMP analytical methods for biologics and small molecule drug substances and drug products .

Posted 9/21/2026full-timeUnited StatesMid-LevelSenior💰 $92,880 - $112,548 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Quality Control for Biologics and Small Molecules, with a strong focus on analytical method validation, regulatory compliance, and continuous improvement initiatives. Proficient in managing documentation and resolving quality issues within a fast-paced environment.

Highest-signal resume keywords

Quality AssuranceAnalytical Method ValidationGMP Documentation ReviewFDA Guidelines KnowledgeElectronic Document Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemAnalytical ChemistryMethod DevelopmentChange ControlCAPA ManagementQuality ControlAnalytical Method ProceduresProtocol ReviewGxP RegulationsQC Laboratory Activities

Soft Skills

Excellent CommunicationAttention to DetailRelationship ManagementNegotiationProblem-SolvingTime Management

Tools & Technologies

DCAVeevaPDLIMSTrackwise

Industry Keywords

BiologicsSmall MoleculeQuality AssuranceQuality ControlGMPRegulatory Compliance

About the role

Key responsibilities & impact

Provide QA review and approval of technical documents and Quality Management System records for Commercial GMP analytical methods for biologics and small molecule drug substances and drug products
Review and approve GMP documentation, including analytical method validation and transfer, analytical method procedures and change controls, protocols, reports and CoAs, and procedural/supporting documents
Collaborate with analytical and operational functions to determine resolutions or CAPAs for protocol deviations and exceptional conditions
Communicate, share, and escalate issues within the AQA team for consensus resolution
Perform Quality approval of QMS records, including change controls, CAPAs, standalone actions, and effectiveness checks
Assist in developing and implementing continuous improvement initiatives for Quality and QC functions

Requirements

What you’ll need

Minimum of 5 years professional experience in Biologics and/or Small Molecule Quality Assurance, Quality Control, analytical chemistry, or method development
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
Previous experience in QC laboratory-facing QA activities is highly desirable
Excellent communication, attention to detail, relationship management, negotiation, problem-solving and personal time management skills
Ability to manage multiple priorities with aggressive timelines
We hire for skills and capabilities, not just credentials

Benefits

Comp & perks

Wellbeing support
Retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) for U.S.-based exempt employees
11 paid company holidays per year
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible employees
Paid sick leave, subject to eligibility
Up to two paid volunteer days per year
Summer hours flexibility
Medical, personal, parental, caregiver, bereavement, or military leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day
Flexible work models and workplace accommodations/adjustments