Senior Director, Compliance & Strategy, MQSA

Bristol Myers Squibb

. Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents .

Posted 9/17/2026full-timeDevens • New Jersey • United StatesSenior💰 $210,190 - $272,528 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in aseptic processing, contamination control, and regulatory compliance within the pharmaceutical industry, with a strong focus on leading enterprise-level strategies and frameworks. Proven ability to influence and drive change across global teams while ensuring adherence to stringent regulatory standards.

Highest-signal resume keywords

Aseptic Processing ExpertiseRegulatory Compliance LeadershipContamination Control StrategyMicrobial Quality AssuranceExecutive-Level Communication

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

MicrobiologyContamination ControlSterility AssuranceRegulatory FrameworksQuality ManagementRisk AssessmentChange ManagementAseptic Training DevelopmentTechnical Compliance SupportPerformance Monitoring

Soft Skills

Strategic ThinkingInfluencing Without AuthorityDecision-MakingTeam LeadershipCommunication Skills

Industry Keywords

Pharmaceutical IndustryFDA 21 CFREU GMPICH Q9/Q10PIC/SCMO/CDMOBiologicsGene TherapyCell TherapyQuality Agreements

About the role

Key responsibilities & impact

Own and maintain the enterprise CCS/SA governance framework, including standards, policies, procedures, and Global Procedural Oversight documents
Provide site Environmental and Aseptic Control governance and oversight
Define and continuously improve enterprise contamination control requirements and risk methodologies
Govern compliance gap assessments and applicability matrices across the manufacturing network
Drive adoption of enterprise standards into site-level operations
Define the enterprise aseptic and microbial control roadmap, strategic objectives, KPIs, and performance monitoring frameworks
Own the enterprise contamination control strategy, CCS frameworks, and harmonization roadmap
Evaluate emerging aseptic processing and microbial control technologies and drive innovation adoption
Provide centralized technical oversight across internal sites and contract partners
Govern regulatory intelligence and surveillance programs and interpret evolving global regulations
Lead change notifications, compliance alignment, and regulatory change impact assessments
Lead enterprise regulatory engagement with health authorities and industry bodies
Provide regulatory interpretation support for internal audits and regulatory inspections
Support inspection readiness at internal manufacturing facilities and contract manufacturers
Provide technical compliance support for regulatory interpretation, microbiological data integrity, critical investigations, and inspection readiness
Serve as an enterprise escalation point for complex or high-risk microbial and sterility assurance matters
Define contractual and quality agreement requirements for CMO/CDMO aseptic practices and microbial control obligations
Oversee compliance assessments and audits of external manufacturing partners
Govern aseptic training, capability development, and competency assurance programs
Maintain and improve the global aseptic training program, content library, and qualification frameworks
Foster aseptic discipline, contamination awareness, and quality mindset across the manufacturing network
Lead external engagement with regulatory agencies, industry consortia, and professional organizations
Represent BMS in benchmarking initiatives and emerging science forums

Requirements

What you’ll need

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
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, including FDA 21 CFR Parts 210/211/600, EU GMP Annex 1 and Part IV, ICH Q9/Q10, USP, PIC/S, and other applicable guidance
Proven experience leading or supporting regulatory inspections, including FDA PAI/GMP, EMA, MHRA, or equivalent
Experience governing CMO/CDMO quality relationships and aseptic compliance requirements
Track record of leading enterprise-wide harmonization and change management programs
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
Ability to influence without direct authority across a global, matrixed organization
Executive-level communication and presentation skills, including engagement with health authorities, senior leadership, and external partners
Strong risk assessment and decision-making capabilities in ambiguous and high-stakes environments
Ability to build, lead, and develop high-performing, globally dispersed teams

Benefits

Comp & perks

Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance
U.S.-based exempt employees: Flexible Time Off (FTO) without a set accrual limit, subject to manager approval
11 paid company holidays each year
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires
3 optional holidays for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico
Paid sick leave, subject to eligibility
Up to two paid volunteer days per year
Summer hours flexibility
Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees
Discretionary incentive cash and stock opportunities
Workplace accommodations/adjustments and ongoing disability support