Associate Director Quality Control, Microbiology

Principal Objective of the Position The Associate Director, Quality Control Microbiology Laboratory Operations is accountable for the strategic leadership, governance, and GMP‑compliant execution of microbiological quality control activities supporting commercial and clinical biologics manufacturing at the Devens site. The role ensures microbiology laboratory operations, systems, and personnel consistently meet regulatory requirements, internal Quality Management System (QMS) standards, and inspection readiness expectations to protect patient safety, product quality, and data integrity. Major Duties and Responsibilities Provide strategic and operational leadership for GMP Microbiology laboratory activities, including environmental and utility monitoring, sterility assurance, microbial testing, and microbiological release support. Establish and maintain laboratory governance, performance metrics, and continuous improvement initiatives aligned with site and global Quality objectives. Ensure all laboratory activities are executed in accordance with approved procedures, validated methods, regulatory filings, and internal quality standards. Drive and participate in compliance‑related teams and initiatives aimed at continuous improvement and operational excellence. Serve as accountable quality leader for microbiology‑related deviations, investigations, CAPAs, and change controls. Maintain continuous inspection readiness and serve as laboratory SME during regulatory inspections, customer audits, and internal audits. Provide independent quality judgment and escalate quality risks to appropriate governance forums. Knowledge and Skill Expert knowledge of GMP microbiology, sterility assurance, environmental monitoring programs, and biologics manufacturing controls. Strong understanding of global regulatory expectations (e.g., FDA, EMA) related to microbiological quality control and data integrity. Demonstrated ability to lead GMP‑impacting teams, influence cross‑functional partners, and drive compliant decision‑making. Proficiency in quality risk management, investigation methodologies, and inspection readiness practices. Qualifications Required: Bachelor’s degree in Microbiology, Biology, Life Sciences, or a related scientific discipline; Minimum of 10 years of progressive experience in GMP microbiology or quality control laboratory operations within the pharmaceutical or biotechnology industry; Demonstrated leadership experience managing GMP laboratories, teams, and quality systems. Preferred: Advanced degree (Master’s or PhD) in Microbiology or related discipline; Experience supporting commercial biologics (sterile) manufacturing and regulatory inspections; Experience overseeing contract laboratories and external GMP service providers. Inspection Readiness Expectations Maintain continuous inspection readiness for microbiology laboratories, systems, and documentation. Ensure personnel training, procedural compliance, and data integrity are inspection‑ready at all times. Lead inspection preparation, execution support, and response development. Additional Compliance Statements This position performs and oversees activities that directly impact GMP compliance and product quality. The Associate Director, Quality Control Micro Lab Operations is accountable for adherence to all applicable policies, procedures, and regulatory requirements. All responsibilities must be executed in alignment with Bristol Myers Squibb’s Quality Management System, Code of Conduct, and commitment to patient safety and data integrity. Compensation Overview Devens - MA - US: $173,280 - $209,976 Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work‑life benefits: Paid Time Off, flexible time off, paid national holidays, optional holidays, unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, annual Global Shutdown between Christmas and New Years Day. 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 View email address on click.appcast.io. Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr