Sr. Director, Compliance & Strategy, MQSA

Bristol-Myers Squibb; Harvard (MA); On-site; USD 210,000 - 272,000; Full time

Job summary

Bristol Myers Squibb seeks a senior leader to oversee enterprise aseptic and microbial control programs, governance, and regulatory alignment across sites and partners.

You will drive the strategy, standards, and compliance activities, coordinating with global health authorities and internal stakeholders to ensure robust contamination control and inspection readiness.

Qualifications

• Education required in a scientific discipline related to microbiology or pharmaceutical sciences.
• 15+ years of progressive pharma experience in microbiology and sterility assurance.
• Senior leadership with enterprise-level accountability across manufacturing and quality.

Responsibilities

• Own and maintain enterprise governance for CCS/SA and related policies.
• Provide EAC governance and regulatory-aligned oversight across facilities.
• Define contamination control requirements and risk methodologies enterprise-wide.
• Drive compliance gap assessments for aseptic and microbial operations.
• Develop and implement enterprise standards across manufacturing networks.
• Lead strategic roadmap, KPIs, and performance monitoring for microbial control.
• Oversee regulatory strategy, inspections, and change impact assessments.
• Support regulatory readiness and interactions with authorities.

Skills

Aseptic processing

Contamination control

Regulatory strategy

Executive communication

Education

Bachelor's degree in Microbiology/Biology/Pharmaceutical Sciences

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
• Provide site 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
• Govern compliance gap assessments and applicability matrices for 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 the enterprise aseptic and microbial control roadmap, including long-range strategic objectives, KPIs, and performance monitoring frameworks
• Own the enterprise contamination 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
• Provide centralized aseptic and microbial control technical oversight across the full manufacturing network, including internal sites and contract partners

Regulatory Intelligence & Compliance Alignment

• Define, maintain, and govern enterprise aseptic 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
• Drive and own change notification, compliance alignment, and regulatory change impact assessments to ensure timely enterprise readiness for evolving regulatory requirements related to aseptic processing
• Lead enterprise aseptic and microbial control regulatory engagement strategy in both sterile and non-sterile manufacturing contexts, including engagement with health authorities and industry bodies.
• Provide regulatory interpretation support for internal audits and regulatory inspections, ensuring consistent, defensible, science-based responses.

Inspection Readiness & Technical Compliance Support

• Support regulatory inspection readiness at internal manufacturing facilities and contract manufacturers, serving as a subject matter expert resource during health authority inspections.
• Provide general and microbiological technical compliance support related 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

• Define contractual and quality agreement requirements for 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 for aseptic training, capability development, and competency assurance, including aseptic technique qualification, gowning qualification, and annual requalification programs.
• Maintain and continuously improve the global 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

• Lead external engagement with 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+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing

Minimum 8–10 years in senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy

Deep experience across multiple manufacturing modalities, including small molecule, biologics, cell therapy, or gene therapy

Demonstrated expertise in global 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 supporting regulatory inspections (FDA PAI/GMP, EMA, MHRA, or equivalent)

Experience governing CMO/CDMO quality relationships and aseptic compliance requirements

Track record of successfully leading enterprise-wide harmonization and change management programs

Competencies & Skills

• Exceptional scientific and technical depth in aseptic processing, contamination control, microbial quality, and sterility assurance
• Strong strategic thinking and ability to translate complex scientific and regulatory requirements into actionable enterprise frameworks
• Proven ability to influence without direct authority across a global, matrixed organization
• Executive-level communication and presentation skills; ability to engage credibly with health authorities, senior leadership, and external partners
• Strong risk assessment and decision-making capabilities 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

Compensation Overview:

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

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