Director, Microbiology Quality, Sterility Assurance

Bristol Myers Squibb

Director of Microbiology Quality at Bristol Myers Squibb overseeing sterility assurance and strategic leadership in microbiological controls. Leading teams in regulated environments with significant experience in aseptic assurance.

Posted 6/13/2026full-timeNew Brunswick • Massachusetts, New Jersey • 🇺🇸 United StatesLead💰 $188,250 - $244,089 per yearWebsite

About the role

Key responsibilities & impact

Strategic Leadership & Sterility Assurance Governance
Embed control contamination and aseptic assurance strategy and aseptic-by-design principles into future processes and product development programs
Lead remediation plans following regulatory observations, ensuring proactive installation of appropriate aseptic assurance standards (QMS and standard work) across the business
Champion continuous improvement initiatives including KPI trending and capability development in aseptic and sterility assurance domains and process confirmations
Own and periodically review BMS's Global CCS as a living document, ensuring it reflects current regulatory requirements
Establish, own, and govern BMS's global sterility/aseptic assurance and CCS performance metrics framework, including KPI definitions, network-level escalation thresholds, trend analysis, and executive-level reporting cadence
Support any implementation of BMS's Sterility Assurance Strategy
Lead CMO support in establishing and executing annual Contamination Control Strategies (CCS) and Aseptic/Sterility Assurance Roadmaps
Partner with CMOs for KPI analysis, trending, escalation, and gap assessments versus BMS standards (GQPs, QMS, FDA Guidance, etc.)
Conduct due diligence activities during onboarding of new CMOs.
Provide deep technical oversight of microbiological controls across pharmaceutical, biopharmaceutical, cell therapy, radiopharmaceutical and drug product manufacturing operations
Lead the identification, qualification, and validation of terminal sterilization suppliers
Provide expert technical guidance across product design, process controls, and organizational capabilities with a focus on microbiological controls
Lead or oversee complex cross-site microbiological investigations, CAPA development, and systemic remediation efforts, ensuring robust root cause analysis and sustainable corrective actions
Maintain in-depth knowledge of global regulations, guidance documents, and industry best practices related to sterility assurance, including: EU GMP, FDA, WHO, PDA, ASTM, ISPE, PhRMA , and BMS internal standards
Support review of regulatory filings related to sterility assurance and microbiology
Lead or actively support sterility assurance-related regulatory inspections globally, including direct engagement with FDA, EMA, MHRA, and other Health Authorities
Lead assessment and adoption of new or updated regulations (e.g. Annex 1)
Ensure CMOs and internal sites maintain inspection readiness at all times
Lead or proactively influence external aseptic/sterility assurance trade associations and industry working groups (e.g., PDA, ISPE, PhRMA)
Represent BMS and proactively influence external scientific and regulatory forums, including Health Authority advisory panels and industry standard-setting bodies
Adapt and embed emerging best practices and industry innovations into BMS operations

Requirements

What you’ll need

Bachelor's degree in a Scientific Discipline, preferably in:
o Microbiology
o Life Sciences
o Biological Sciences
Significant and progressive experience in aseptic or bioburden control manufacturing environments (production, QA, and/or validation), with demonstrated successful results in an Health Authority-regulated environment (e.g. FDA, MHRA, EMA, TGA)
10+ years of people management experience , with a track record of leading large, globally distributed teams
Proven experience in aseptic/sterility assurance across pharmaceutical, biopharmaceutical, medical device industries
Experience leading or supporting regulatory inspections and PAIs including direct engagement with Health Authorities (FDA, EMA, MHRA) as the senior technical SME

Benefits

Comp & perks

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

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Hard Skills & Tools

aseptic assurancesterility assurancemicrobiological controlsKPI analysisroot cause analysisCAPA developmentterminal sterilizationregulatory complianceprocess controlsbioburden control

Soft Skills

strategic leadershippeople managementcross-site collaborationcommunicationinfluencingcontinuous improvementtechnical guidanceproblem-solvingorganizational capabilitiesstakeholder engagement