Senior Director, Aseptic Operational Support

Bristol Myers Squibb

. Govern enterprise aseptic and microbial control practices, escalation pathways, cross-functional forums, and decision frameworks .

Posted 9/17/2026full-timeNew Brunswick • New Jersey • United StatesSenior💰 $218,880 - $283,796 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in sterility assurance, contamination control, and aseptic processing, with a strong focus on regulatory compliance and quality management in the pharmaceutical industry. Proven ability to lead cross-functional teams and drive enterprise-wide strategies for risk management and operational excellence.

Highest-signal resume keywords

Sterility AssuranceContamination ControlAseptic ProcessingRegulatory ComplianceQuality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

MicrobiologyPharmaceutical SciencesEnvironmental MonitoringPerformance DashboardsTrend AnalyticsRisk ManagementCAPARegulatory FrameworksAseptic ComplianceChange Management

Soft Skills

Executive CommunicationCross-Functional PartnershipInfluencing Without Authority

Industry Keywords

FDA 21 CFR Parts 210/211/600EU GMP Annex 1ICH Q9/Q10USPPIC/SCMO/CDMO Quality RelationshipsManufacturing FacilitiesBiologicsCell TherapyGene Therapy

About the role

Key responsibilities & impact

Govern enterprise aseptic and microbial control practices, escalation pathways, cross-functional forums, and decision frameworks
Provide executive leadership for Quality Council and EAC activities involving sterility assurance and contamination control
Define enterprise policies, standards, procedures, roadmap, KPIs, and performance monitoring for aseptic operations and microbial control
Lead enterprise trend detection, signal monitoring, recurring event analysis, and executive risk insights
Drive cross-site harmonization across the global manufacturing network
Build and sustain a Community of Practice for sterility assurance and contamination control
Lead knowledge management initiatives, converting learnings from deviations, audits, and industry trends into prevention actions and training
Serve as enterprise technical authority for sterility assurance, contamination control, aseptic processing, and microbial risk management
Provide expertise for technology transfers, PPQ readiness, and commercialization across internal and external manufacturing sites
Lead oversight of high-risk, systemic, or cross-site contamination events, including impact assessments, root cause investigations, and CAPAs
Represent BMS in regulatory inspections, agency interactions, and industry forums
Define and govern environmental monitoring program requirements, standards, sampling plans, frequencies, and personnel sampling
Modernize environmental monitoring standards in alignment with regulatory expectations and industry best practices
Monitor CMO performance indicators and risk signals; provide technical input for escalations, deviations, investigations, and technology transfers
Conduct risk-tiered CMO assessments and implement standardized oversight tools, dashboards, and decision trees
Govern gowning qualification and sequence standards
Define personnel, material, and waste flow strategies to minimize contamination risk
Support facility design reviews and cleanroom classification initiatives

Requirements

What you’ll need

Required: Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
Minimum 8–10 years in senior leadership roles with enterprise-level accountability for quality, compliance, or regulatory strategy
Deep experience working in manufacturing facilities across multiple modalities, including small molecule, biologics, cell therapy, or gene therapy
Expertise in global regulatory frameworks, including FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, Part IV for Advanced Therapies, ICH Q9/Q10, USP, and PIC/S
Experience leading or supporting regulatory inspections, including FDA PAI/GMP, EMA, MHRA, or equivalent
Experience governing CMO/CDMO quality relationships and aseptic compliance requirements
Track record leading enterprise-wide harmonization and change management programs
Ability to translate site-level data into network-wide strategy and risk management decisions
Recognized authority in aseptic sciences, contamination control, and environmental monitoring
Executive communication skills for senior leadership, regulatory agencies, and external partners
Ability to influence without direct authority across a complex, matrixed global organization
Proficiency with performance dashboards, trend analytics, and KPIs
Strong cross-functional partnership skills across Quality, Operations, MS&T, Regulatory, and Supply Chain
Advanced degree (M.S. or Ph.D.) in Microbiology or related field 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 eligible U.S.-based exempt employees
11 paid company holidays annually
160 hours of paid vacation annually for eligible non-exempt, RayzeBio, and Puerto Rico employees
3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees
Paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs, depending on eligibility
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Additional discretionary incentive cash and stock opportunities
Workplace accommodations/adjustments and ongoing support for people with disabilities