Associate Director, MQSA Regulatory Intelligence and Standards

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

Regulatory Intelligence & Compliance Alignment

Execute the enterprise regulatory intelligence and surveillance program; monitor, analyze, and interpret evolving global regulations, guidance documents, and Health Authority expectations related to aseptic processing, contamination control, and microbial quality (FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP <797>/<1072>/<71>, PIC/S). Owns updates to global procedures based on the assessments.

Conduct systematic regulatory change impact assessments and draft change notification packages; escalate significant compliance gaps or emerging regulatory risks for strategic assessment and enterprise response.

Maintain the regulatory intelligence deliverables library, including gap assessments, applicability matrices, regulatory horizon scanning summaries, and compliance position papers to ensure enterprise-wide readiness.

Support regulatory engagement strategy with Health Authorities and industry bodies; serve as a primary operational contact during site inspections, agency inquiries, and regulatory filings related to CCS/SA matters.

Translate regulatory intelligence findings into actionable recommendations, briefing documents, and compliance alignment proposals.

Enterprise Governance & Standards

Own and maintain commercial CCS/SA governance documentation, including global procedural documents (GPOs), policies, and standards — ensuring alignment with the overarching enterprise governance framework.

Execute compliance gap assessments and applicability matrices across aseptic processes, microbial control, and sterility assurance for all relevant manufacturing environments (sterile, aseptic, non-sterile).

Drive the practical adoption and operationalization of enterprise standards at site level, working closely with site quality teams to ensure scalable and sustainable implementation.

Establish and maintain governance documents, white papers, storyboards and inspection-ready deliverables supporting the enterprise CCS/SA framework.

Support the organizational transition from current-state to a single, unified enterprise CCS/SA function with clear decision rights, including workforce transition planning and role definition activities.

Inspection Readiness & Technical Compliance Support

Lead day-to-day inspection readiness activities across the commercial manufacturing network related to CCS/SA; serve as the primary operational subject matter expert resource during Health Authority inspections and agency engagements related to CCS/SA.

Develop and maintain inspection-ready documentation packages, site-level compliance assessments, and regulatory response materials for CCS/SA-related matters.

Provide technical compliance support related to regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness activities; escalate complex or high-risk matters to the Senior Director as the enterprise escalation point.

Coordinate with site quality teams and cross-functional partners to ensure consistent, defensible, science-based responses during regulatory inspections and agency interactions.

Strategy, Roadmap & Performance

Contribute to the development of the enterprise CCS/SA roadmap, including input on emerging regulatory requirements, site-level performance gaps, and practical implementation considerations, in support of strategic direction.

Develop and maintain performance monitoring inputs, tracking site-level compliance performance against enterprise CCS/SA standards.

Define integrated CCS/SA minimum requirements and decision frameworks applicable across the BMS commercial manufacturing network, consistent with the enterprise strategy.

CMO/CDMO Standards & Oversight (Operational Accountability)

Establish and maintain CCS/SA standards in CMO/CDMO quality agreements, defining minimum sterility assurance content requirements and standardizing oversight expectations across the ExM network.

Coordinate with ExM Compliance and Strategy to ensure external partners meet BMS enterprise standards and applicable regulatory expectations, consistent with contractual and quality agreement requirements.

Support compliance assessments and audits of external manufacturing partners related to aseptic and microbial control performance.

Cross-Site Learning, Community of Practice & Capability Development (Network Enablement)

Drive cross-site learning, community of practice initiatives, and standardized approaches that promote continuous improvement across the Product Development & Supply (PDS)network.

Support the enterprise aseptic training program by developing and maintaining training content, qualification frameworks, and competency assurance tools, ensuring practical translation into demonstrable improvements in aseptic behaviours and contamination control practices.

Foster a culture of aseptic discipline, contamination awareness, and quality mindset across manufacturing sites and network partners.

Coordinate with PD Micro (Micro CoE) to ensure alignment on adoption of new technologies and to provide technical context when central MQSA documents or standards intersect with PD activities.

External Engagement & Industry Benchmarking (Supporting Enterprise Representation)

Participate in and support external engagement with regulatory agencies, industry consortia, and professional organizations (e.g., PDA, ISPE, USP expert committees), to monitor the evolving regulatory landscape and benchmark against industry-validated practices.

Represent MQSA in applicable benchmarking initiatives and emerging science forums, translating external intelligence into meaningful business action and recommendations for leadership.

Qualifications & Experience:

Education

Required: B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

Experience

Bachelor's degree or equivalent in a relevant scientific discipline (Microbiology, Pharmacy, Life Sciences, or related field) with a minimum of 14 years of relevant experience.

Demonstrates advanced knowledge and practical experience of sterility assurance, contamination control strategy, and aseptic processing within a biopharmaceutical commercial manufacturing environment; recognized as an industry expert in CCS/SA regulatory compliance.

Extensive experience engaging with global Health Authorities (FDA, EMA, PMDA, etc.) in the context of site inspections, agency responses, and regulatory filings related to microbiology and sterility assurance.

Demonstrated expertise in developing and implementing enterprise-level governance frameworks, global quality standards, policies, and decision frameworks within a regulated biopharma environment.

Experience in corporate quality roles with accountability across multiple modalities (biologics, cell therapy, external manufacturing) preferred.

Supervisory experience in leading cross-functional or compliance-focused teams.

Demonstrated skills in cross-functional partnership, including collaboration with Technical, Quality, and Operations functions at both site and above-site levels.

Strong understanding of cGMP regulations, relevant pharmacopeial standards (USP, EP, JP), and industry guidance applicable to aseptic processing and sterility assurance.

Strong organizational, communication, and technical writing skills are required.

Travel

• This position requires up to 10% of travel.

Preferred:

• M.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline.

#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: $175,310 - $212,438

Madison - Giralda - NJ - US: $163,850 - $198,543

New Brunswick - NJ - US: $163,850 - $198,543

Princeton - NJ - US: $163,850 - $198,543

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.

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 [email protected]. 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 [email protected] 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.

R1606475 : Associate Director, MQSA Regulatory Intelligence and Standards