Executive Director, Microbiology Quality Sterility Assurance

Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: Summary

The Executive Director Microbiology Quality Sterility Assurance (MQSA) is a pivotal global leadership role within BMSs Corporate Quality organization. This position brings critical expertise in sterility assurance microbiological controls and contamination control strategy across BMSs internal and external commercial and PD manufacturing sites spanning pharmaceutical biopharmaceutical cell therapy and radiopharmaceuticals. This role is responsible for defining owning and governing BMSs 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 BMSs 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 BMSs global network.

Key Responsibilities
Strategic Leadership & Sterility Assurance Governance

Define own and drive BMSs 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 BMSs Global CCS as a living document ensuring it reflects current regulatory requirements

• Establish own and govern BMSs 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 BMSs Sterility Assurance Strategy

• Lead CMO support in establishing and executing annualContamination 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 ofmicrobiological controlsacross pharmaceutical biopharmaceutical cell therapy radiopharmaceutical and drug product manufacturing operations

• Lead theidentification qualification and validationof 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 ofbusiness planning capital planning and business case developmentto 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 influenceexternal aseptic/sterility assurance trade associationsand 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 embedemerging best practices and industry innovationsinto 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 oftraining 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:

Bachelors degree in a Scientific Discipline preferably in:

o Microbiology

o Life Sciences

oBiological 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

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:

o Microbiology

o Industrial Microbiology

o Clinical Microbiology

o Bacterial Toxicology

Preferred:

Experience working within or managing CMO partnerships in a quality assurance capacity

Experience in due diligence for CMO onboarding and new product launchs

Experience with industry standard-setting activities through PDAISPE Phr MA or equivalent organization

This position requires 30-50% travel.

#LI-Hybrid

BMSBL

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. 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

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.

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 and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.