Associate Director Quality Control, Microbiology

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 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. Lead inspection preparation, execution support, and response development. BMSBL If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $173,280 - $209,976 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: 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. *Eligibility Disclosure: 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. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1601440 : Associate Director Quality Control, Microbiology Data Privacy Link We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.