Executive Director, Microbiology Quality Sterility Assurance

Executive Director, Microbiology Quality Sterility Assurance Position Summary: The Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's Corporate Quality organization. This position brings critical expertise in sterility assurance, microbiological controls, and contamination control strategy across BMS's internal and external commercial and PD manufacturing sites — spanning pharmaceutical, biopharmaceutical, cell therapy and radiopharmaceuticals. The role is responsible for defining, owning, and governing BMS's enterprise‑wide Contamination Control Strategy (CCS) as a living, risk‑based framework ensuring alignment with EU GMP Annex 1, FDA, and all applicable global regulatory standards. Key Responsibilities Strategic Leadership & Sterility Assurance Governance Define, own, and drive BMS's Global Sterility & Microbiology Assurance Strategy, ensuring alignment across all manufacturing sites, CMOs, MS&T, GTS and PD partners. Serve as the primary executive‑level contact for contamination control and sterility assurance across Operations, Engineering, MS&T and PD. 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 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, 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 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. 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. Drive the adoption of advanced analytics, digital environmental monitoring tools and data‑driven risk assessment approaches to enhance contamination surveillance and EM trending across the network. 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. 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. Ensure CMOs and internal sites maintain inspection readiness at all times. Business Planning & Capital Strategy Apply understanding of business planning, capital planning and business case development to help drive aseptic/sterility assurance investment decisions. Balance technical, compliance and business attributes in the decision‑making process, demonstrating strong business acumen. Proactively engage and align stakeholders, capabilities and resources to achieve company objectives. Support identification of business solutions to enhance aseptic and low‑bioburden manufacturing processes, improving robustness and operational efficiency. External Advocacy Lead or proactively influence external aseptic/sterility assurance trade associations and industry working groups. Represent BMS and 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. People Leadership & Capability Development Lead, inspire and develop a high‑performing, globally distributed team of sterility assurance and microbiology professionals. Build the newly established central MQSA function from the ground up, defining team structure, roles, operating model and ways of working in partnership with senior leadership. Build aseptic/sterility assurance and microbiological capability across the broader BMS organization through delivery of training, coaching and mentoring programs. Develop technical talent pipelines, supporting career growth and succession planning within the Quality function. Energize and align cross‑functional teams and business partners toward a shared quality vision. Foster a culture of contamination prevention, quality ownership and continuous learning across all sites and functions within the MQSA community of practice. Qualifications & Experience Bachelor's degree in a scientific discipline such as Microbiology, Life Sciences or Biological Sciences. Significant and progressive experience in aseptic or bioburden control manufacturing environments (production, QA and/or validation) with demonstrated results in a Health Authority‑regulated environment. 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 and medical device industries. Experience leading or supporting regulatory inspections and PAIs, including direct engagement with Health Authorities such as FDA, EMA and MHRA. Demonstrated ability to lead through influence in a complex, global matrix organization, driving cross‑functional alignment across operations, engineering, regulatory and PD stakeholders without direct line authority. Executive presence with demonstrated ability to communicate and influence at VP/SVP/C‑Suite level. Preferred Advanced degree (MS, MPhil, PhD, MTD) in Microbiology, Industrial Microbiology, Clinical Microbiology or Bacterial Toxicology. Experience working within or managing CMO partnerships in a quality assurance capacity. Experience in due diligence for CMO onboarding and new product launch’s. Experience with industry standard‑setting activities through PDA, ISPE, PhRMA or equivalent organization. Travel This position requires 30‑50% travel. Compensation Overview © $260,860 - $316,097 Starting compensation range is listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities may be available. Final, individual compensation will be decided based on demonstrated experience. Benefit Offerings 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. 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. Paid Time Off and Additional Leave: Unlimited paid time off for US exempt employees with manager approval, 160 hours annual paid vacation for certain non‑exempt employees, optional holidays, paid sick time, volunteer days, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement and military needs, and a global shutdown between Christmas and New Years Day. Equal Employment Opportunity BMS is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, gender identity, sexual orientation, national origin, age or disability status. #J-18808-Ljbffr