Associate Director, MQSA Regulatory Intelligence and Standards

Bristol Myers Squibb

. Execute the enterprise regulatory intelligence and surveillance program for aseptic processing, contamination control, and microbial quality .

Posted 9/17/2026full-timeNew Brunswick • New Jersey • United StatesSenior💰 $163,850 - $212,438 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced knowledge in Sterility Assurance, Contamination Control Strategy, and Aseptic Processing within a biopharmaceutical manufacturing environment, alongside expertise in Regulatory Compliance and Governance Frameworks. Proven ability to engage with global Health Authorities and lead cross-functional teams in compliance-focused initiatives.

Highest-signal resume keywords

Sterility Assurance ExpertiseRegulatory Compliance EngagementAseptic Processing KnowledgeCross-Functional Team LeadershipCGMP Regulations Understanding

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Aseptic ProcessingContamination Control StrategyRegulatory Change Impact AssessmentTechnical WritingGovernance Framework DevelopmentCompliance Position PapersInspection ReadinessMicrobiological Data IntegrityQuality Standards ImplementationRegulatory Filings

Soft Skills

Strong CommunicationOrganizational Skills

Industry Keywords

Health Authority EngagementCGMP RegulationsUSPEPJPBiopharmaceutical ManufacturingQuality AgreementsCompliance AssessmentsCross-Site LearningCommunity of Practice Initiatives

About the role

Key responsibilities & impact

Execute the enterprise regulatory intelligence and surveillance program for aseptic processing, contamination control, and microbial quality
Monitor, analyze, and interpret global regulations, guidance documents, and Health Authority expectations
Update global procedures based on regulatory assessments
Conduct regulatory change impact assessments and draft change notification packages
Escalate significant compliance gaps and emerging regulatory risks
Maintain regulatory intelligence deliverables, gap assessments, applicability matrices, horizon-scanning summaries, and compliance position papers
Support Health Authority and industry engagement, inspections, agency inquiries, and regulatory filings related to CCS/SA
Own commercial CCS/SA governance documentation, global procedures, policies, and standards
Drive adoption of enterprise standards with site quality teams across manufacturing environments
Support the transition to a unified enterprise CCS/SA function, including workforce transition planning and role definitions
Lead inspection readiness activities across the commercial manufacturing network
Develop inspection-ready documentation, site compliance assessments, and regulatory response materials
Provide technical compliance support for regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness
Coordinate science-based responses with site quality and cross-functional partners
Contribute to the enterprise CCS/SA roadmap and maintain site-level compliance performance monitoring
Define CCS/SA minimum requirements and decision frameworks across the BMS commercial manufacturing network
Establish CCS/SA standards in CMO/CDMO quality agreements and coordinate external partner oversight
Support compliance assessments and audits of external manufacturing partners
Drive cross-site learning, community of practice initiatives, and standardized approaches across the PDS network
Develop and maintain aseptic training content, qualification frameworks, and competency assurance tools
Foster aseptic discipline, contamination awareness, and quality mindset
Coordinate with PD Micro on new technologies and intersections between MQSA and PD activities
Participate in regulatory agency, industry consortium, and professional organization engagement and benchmarking
Represent MQSA in benchmarking initiatives and emerging science forums

Requirements

What you’ll need

Required B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
Bachelor's degree or equivalent in a relevant scientific discipline with a minimum of 14 years of relevant experience
Advanced knowledge and practical experience of sterility assurance, contamination control strategy, and aseptic processing in a biopharmaceutical commercial manufacturing environment
Recognized as an industry expert in CCS/SA regulatory compliance
Extensive experience engaging with global Health Authorities, including FDA, EMA, and PMDA, regarding inspections, agency responses, and regulatory filings
Expertise developing and implementing enterprise-level governance frameworks, global quality standards, policies, and decision frameworks in regulated biopharma
Corporate quality experience across multiple modalities preferred
Supervisory experience leading cross-functional or compliance-focused teams
Cross-functional partnership with Technical, Quality, and Operations functions at site and above-site levels
Strong understanding of cGMP regulations, USP, EP, JP, and industry guidance for aseptic processing and sterility assurance
Strong organizational, communication, and technical writing skills
Up to 10% travel
M.S. in a related scientific discipline preferred

Benefits

Comp & perks

Comprehensive 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 each year
160 hours of paid vacation annually for eligible new hires
3 optional holidays for eligible employees
Paid sick leave
Up to two paid volunteer days per year
Summer hours flexibility
Medical, personal, parental, caregiver, bereavement, and military leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day
Additional discretionary incentive cash and stock opportunities
Reasonable workplace accommodations/adjustments and ongoing support
Flexible work models, including site-essential, site-by-design, field-based and remote-by-design