Director, Microbiology Quality Sterility Assurance

Responsibilities

• 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
• CMO & External Partner Management
• 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.
• Drive alignment in ways of working and standard operating procedures between all CMO partners in aseptic/sterility assurance subjects
• Microbiological Quality & Technical Oversight
• 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
• Regulatory & Compliance
• 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
• External Advocacy
• 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
• Qualifications & Experience:
• Required:
• 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
• If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encoura

Benefits

Additional Information

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

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