Sr. Director, Compliance & Strategy, MQSA

Bristol Myers Squibb; Harvard (MA); On-site; USD 225,000 - 273,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work options

Wellbeing support

Job summary

Bristol Myers Squibb seeks a Sr. Director, Compliance & Strategy, MQSA to drive enterprise aseptic and microbial control governance, strategy, and regulatory alignment across multiple manufacturing networks from Devens, MA.

You will oversee technical compliance, supplier governance, and cross-functional leadership to ensure inspection readiness. The role requires deep expertise in sterility assurance, GMPs, and regulatory expectations, plus a proven ability to lead complex, matrixed teams and

Qualifications

• Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 15+ years in the pharmaceutical industry focusing on microbiology, sterility, contamination control, or aseptic processing.
• 8–10 years in senior leadership with enterprise-level accountability across manufacturing, quality, or regulatory strategy.
• Global regulatory frameworks knowledge (FDA/ICH/ISO) and experience with regulatory inspections.
• Experience governing CMO/CDMO quality relationships and enterprise-wide harmonization programs.

Responsibilities

• Define and maintain enterprise aseptic/ microbial governance, standards, policies and oversight.
• Lead strategy for contamination control roadmaps across manufacturing networks.
• Provide regulatory intelligence and alignment across sterile and non-sterile contexts and engage health authorities.

Skills

Aseptic processing

Contamination control

Microbial quality

Sterility assurance

Strategic thinking

Executive communication

Influence without authority

Education

Bachelor's degree in Microbiology or related

Job description

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.

Key Responsibilities

Enterprise Governance & Frameworks

• Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents (GPOs) spanning sterile, aseptic, and microbial control practices across all modalities and manufacturing environments
• Providesite Environmental and Aseptic Control (EAC) governance and oversight, ensuring alignment with enterprise standards and regulatory expectations
• Define, maintain, and continuously improve the enterprise contamination control requirements and risk methodologies applicable to all product types and manufacturing settings
• Governcompliance gap assessments and applicability matricesfor aseptic processes, microbial control, and SA requirements across the internal and external manufacturing network
• Drive adoption of enterprise standards into site-level operations, ensuring practical, scalable and sustainable implementation

Strategy, Roadmap & Performance

• Define theenterprise aseptic and microbial control roadmap, including long-range strategic objectives, KPIs, and performance monitoring frameworks
• Own the enterprisecontamination control strategy, CCS frameworks, and harmonization roadmap— integrating sterile, aseptic, and non-sterile manufacturing programs into a cohesive, risk-based enterprise approach
• Identify and evaluate emerging aseptic processing and microbial control technologies, driving industry benchmarking and innovation adoption into enterprise strategy
• Providecentralized aseptic and microbial control technical oversightacross the full manufacturing network, including internal sites and contract partners

Regulatory Intelligence & Compliance Alignment

• Define, maintain, and govern enterpriseaseptic and microbial regulatory intelligence and surveillance programs, including systematic interpretation of evolving global regulations, guidance, and expectations related to aseptic processing, contamination control, and microbial quality
• Driveand own change notification, compliance alignment, and regulatory change impact assessmentsto ensure timely enterprise readiness for evolving regulatory requirements related to aseptic processing
• Leadenterprise aseptic and microbial control regulatory engagement strategyin both sterile and non-sterile manufacturing contexts, including engagement with health authorities and industry bodies.
• Provideregulatory interpretation supportfor internal audits and regulatory inspections, ensuring consistent, defensible, science-based responses.

Inspection Readiness & Technical Compliance Support

• Supportregulatory inspection readinessat internal manufacturing facilities and contract manufacturers, serving as a subject matter expert resource during health authority inspections.
• Providegeneral and microbiological technical compliance supportrelated to regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness activities.
• Serve as an enterprise escalation point for complex or high-risk microbial and sterility assurance compliance matters.

CMO/CDMO Governance

• Definecontractual and quality agreement requirementsfor CMO/CDMO aseptic practices, sterility assurance, and microbial control obligations,ensuring external partners meet BMS enterprise standards and applicable regulatory expectations.
• Oversee compliance assessments and audits of external manufacturing partners related to aseptic and microbial control performance.

Training, Capability & Competency Development

• Define and govern enterprise requirements foraseptic training, capability development, and competency assurance, including aseptic technique qualification, gowning qualification, and annual requalification programs.
• Maintain and continuously improve theglobal aseptic training program, content library, and qualification frameworks across all manufacturing sites and personnel categories.
• Foster a culture of aseptic discipline, contamination awareness, and quality mindset across the manufacturing network.
• Ensure training programs translate into demonstrable improvements in aseptic behaviors, contamination control practices, and inspection readiness.

External Engagement & Industry Leadership

• Leadexternal engagementwith regulatory agencies, industry consortia, and professional organizations (e.g., PDA, ISPE, USP expert committees) to shape industry standards and best practices.
• Represent BMS in benchmarking initiatives and emerging science forums related to aseptic processing and microbial control.

Qualifications & Experience

Education

• Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline

Experience

• 15+ yearsof progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing
• Minimum8–10 yearsin senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy
• Deep experience across multiple manufacturing modalities, includingsmall molecule, biologics, cell therapy, or gene therapy
• Demonstrated expertise inglobal regulatory frameworks(FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP <797>/<1072>/<71>, PIC/S, and other applicable guidance)
• Proven experience leading or supportingregulatory inspections(FDA PAI/GMP, EMA, MHRA, or equivalent)
• Experience governingCMO/CDMO quality relationshipsand aseptic compliance requirements
• Track record of successfully leading enterprise-wideharmonization and change management programs

Competencies & Skills

• Exceptionalscientific and technical depthin aseptic processing, contamination control, microbial quality, and sterility assurance
• Strongstrategic thinkingand ability to translate complex scientific and regulatory requirements into actionable enterprise frameworks
• Proven ability toinfluence without direct authorityacross a global, matrixed organization
• Executive-levelcommunication and presentationskills; ability to engage credibly with health authorities, senior leadership, and external partners
• Strongrisk assessment and decision-makingcapabilities in ambiguous and high-stakes environments
• Demonstrated ability to build, lead, and develop high-performing, globally dispersed teams

Preferred

• Advanced degree (M.S. or Ph.D.) in Microbiology or a related field

#LI- Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Devens - MA - US: $224,900 - $272,528Madison - Giralda - NJ - US: $210,190 - $254,698New Brunswick - NJ - US: $210,190 - $254,698Princeton - NJ - US: $210,190 - $254,698

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. (https://careers.bms.com/life-at-bms/ways-of-working/)

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 [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606479 : Sr. Director, Compliance & Strategy, MQSA

Req Number

R1606479

Location

Devens - Massachusetts - US

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.