Sr. Director, Compliance & Strategy, MQSA

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 - $272,528&#xa;Madison - Giralda - NJ - US: $210,190 - $254,698&#xa;New Brunswick - NJ - US: $210,190 - $254,698&#xa;Princeton - NJ - US: $210,190 - $254,698 &#xa;

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 athttps://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.

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 adastaffingsupport@bms.com. 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 TAEnablement@bms.comwith 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