Associate Director Quality Control, Microbiology

Bristol Myers Squibb • Devens, MA

22h

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

• 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.
• 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.

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.

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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

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