Bristol-Myers Squibb
Senior Manager, Quality Assurance - Lab Operations
Bristol-Myers Squibb, Harvard, Massachusetts, us, 01451
Working with Us
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. Position Summary
The Senior Manager, Quality Assurance - Lab Operations is responsible for leading QA oversight of laboratory operations supporting GMP testing, method validation, and stability programs in a biotechnology manufacturing environment. This role ensures that all laboratory activities are conducted in compliance with applicable regulations, internal procedures, and industry best practices. The position plays a key role in maintaining data integrity, supporting regulatory inspections, and driving continuous improvement across quality control laboratories. Key Responsibilities
Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies. Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data. Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations. Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions. Manage and mentor a team of QA professionals supporting lab operations. Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents. Participate in internal audits and regulatory inspections as a QA representative and subject matter expert. Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture. Qualifications & Experience
Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare). Strong leadership, communication, and interpersonal skills. Ability to manage multiple priorities in a fast-paced environment. Experience supporting regulatory inspections (FDA, EMA, etc.). Bachelor’s or Master’s degree in Life Sciences, Chemistry, or a related field. 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment. 3+ years of leadership or management experience. Strong understanding of analytical testing, method validation, and stability programs for biologics. In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles. The starting compensation for this job is a range from US-MA- $ 130,020-$157,600 plus incentive cash and stock opportunities (based on eligibility). 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 & Benefits
The starting compensation range for this role is listed above. Additional incentive cash and stock opportunities may be available based on eligibility. Eligibility for specific benefits listed on our careers site may vary by location. For benefits information, visit careers.bms.com/life-at-bms. Benefit offerings are subject to the terms and conditions of the applicable plans and may include medical, pharmacy, dental and vision care; wellbeing programs; financial well-being resources; 401(k); disability and life insurance; travel protection; paid holidays; vacation; volunteer time; sick time; parental, caregiver, bereavement, and military leave; adoption and surrogacy support; fertility benefits; tuition reimbursement; and recognition programs. 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 upholding our values of passion, innovation, urgency, accountability, inclusion and integrity. 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 roles. The occupancy type is determined by the nature and responsibilities of the role: site-essential roles require 100% onsite shifts; site-by-design roles may be eligible for hybrid work with at least 50% onsite; field-based and remote-by-design roles require ability to travel to visit customers, patients or partners as directed. BMS is dedicated to ensuring accessibility for applicants with disabilities and provides accommodations in the recruitment process. For accommodation inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for more information. BMS encourages vaccination and suggests staying up to date with Covid-19 boosters. Employment decisions will consider arrest and conviction records as permitted by law. For California residents, please visit the California residents page for additional information. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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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. Position Summary
The Senior Manager, Quality Assurance - Lab Operations is responsible for leading QA oversight of laboratory operations supporting GMP testing, method validation, and stability programs in a biotechnology manufacturing environment. This role ensures that all laboratory activities are conducted in compliance with applicable regulations, internal procedures, and industry best practices. The position plays a key role in maintaining data integrity, supporting regulatory inspections, and driving continuous improvement across quality control laboratories. Key Responsibilities
Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies. Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data. Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations. Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions. Manage and mentor a team of QA professionals supporting lab operations. Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents. Participate in internal audits and regulatory inspections as a QA representative and subject matter expert. Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture. Qualifications & Experience
Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare). Strong leadership, communication, and interpersonal skills. Ability to manage multiple priorities in a fast-paced environment. Experience supporting regulatory inspections (FDA, EMA, etc.). Bachelor’s or Master’s degree in Life Sciences, Chemistry, or a related field. 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment. 3+ years of leadership or management experience. Strong understanding of analytical testing, method validation, and stability programs for biologics. In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles. The starting compensation for this job is a range from US-MA- $ 130,020-$157,600 plus incentive cash and stock opportunities (based on eligibility). 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 & Benefits
The starting compensation range for this role is listed above. Additional incentive cash and stock opportunities may be available based on eligibility. Eligibility for specific benefits listed on our careers site may vary by location. For benefits information, visit careers.bms.com/life-at-bms. Benefit offerings are subject to the terms and conditions of the applicable plans and may include medical, pharmacy, dental and vision care; wellbeing programs; financial well-being resources; 401(k); disability and life insurance; travel protection; paid holidays; vacation; volunteer time; sick time; parental, caregiver, bereavement, and military leave; adoption and surrogacy support; fertility benefits; tuition reimbursement; and recognition programs. 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 upholding our values of passion, innovation, urgency, accountability, inclusion and integrity. 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 roles. The occupancy type is determined by the nature and responsibilities of the role: site-essential roles require 100% onsite shifts; site-by-design roles may be eligible for hybrid work with at least 50% onsite; field-based and remote-by-design roles require ability to travel to visit customers, patients or partners as directed. BMS is dedicated to ensuring accessibility for applicants with disabilities and provides accommodations in the recruitment process. For accommodation inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for more information. BMS encourages vaccination and suggests staying up to date with Covid-19 boosters. Employment decisions will consider arrest and conviction records as permitted by law. For California residents, please visit the California residents page for additional information. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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