Executive Director, Microbiology Quality Sterility Assurance

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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. 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.

The Executive Director serves as the global Single Point of Contact (SPOC) for all sterility assurance and microbiology quality matters, partnering with Product Development (PD), Materials Science & Technology (MSAT), Quality, Internal Manufacturing, and External Manufacturing (EXM) to ensure the highest standards of microbiological control are embedded across BMS's manufacturing network.

This is a highly strategic and visible role, operating at the intersection of technical excellence, regulatory compliance, contamination control governance, business planning, and people leadership — with significant influence at the senior executive level.

The Executive Director is expected to build and lead this newly established central function, establishing it as a center of excellence for CCS and sterility assurance across BMS's global network.

• 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 (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

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

Lead assessment and adoption of 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

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 (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 a septic/ 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:
• 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 sup