Associate Director Quality Control, Microbiology

Bristol Myers Squibb • Devens, MA

19h • Onsite

About 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.

Requirements

• 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.
• 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.
• Maintain continuous inspection readiness for microbiology laboratories, systems, and documentation.
• Ensure personnel training, procedural compliance, and data integrity are inspection-ready at all times.

Nice To Haves

• 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.

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.
• Lead inspection preparation, execution support, and response development.

Benefits

• 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 include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees