Executive Director, Microbiology Quality Sterility Assurance
About the role
The Executive Director, Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMS's Corporate Quality organization. This 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.
Responsibilities
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.
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:
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.
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, 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.
Assess and adopt new or updated regulations (e.g. Annex 1).
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.
Balanced 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 (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.
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, preferably in: Microbiology, Life Sciences, 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).
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, both internally and with external regulatory agencies and industry bodies.
Preferred
Advanced degree (MS, MPhil, PhD, MTD) in one of the following areas: Microbiology, Industrial Microbiology, Clinical Microbiology, 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
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Benefits
Our benefits include: 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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work.