Bristol Myers Squibb · 1 week ago
Sr. Manager, Quality Assurance for Quality Control
Indianapolis, IN
Full-time
Onsite
Senior Level, Lead/Staff
$142K/yr - $171K/yr
10+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival of people with cancer. The Senior Manager, QA for QC is responsible for quality oversight of the Quality Control laboratory operations, providing support for sample management, testing, data review, and regulatory audits.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Quality Assurance support and oversight of QC (Analytical and Microbiological) laboratory operations including laboratory investigations, deviations, corrective or preventative actions, method development, validation, and transfer activities, equipment validation work and associated projects
Quality Assurance support of QC associated with the manufacturing process including QC activity related to in process and release product testing, raw material testing, and environmental monitoring activities
Assesses QC driven change controls and supports completion of any associated change actions
Participates in ongoing laboratory operations/continuous improvement and risk management projects
Participates in risk assessments related to QC laboratory operations
Identifies and reports discrepancies from required work practices or procedures to management
Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate
Participates as requested in the response team for audits and inspections by health authorities
Conducts regular walkthroughs of QC laboratories
Performs review and approval of Quality, Laboratory, and Analytical Standard Operating Procedures (SOPs) and documents
Provides oversight to identify and implement changes that lead to realization of long-term department and company goals
Qualification
Required
Bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required
Minimum 10+ years relevant work experience (analytical development, Quality Control, and/or Quality Assurance), preferably in a regulated environment is required
Knowledge of analytical method lifecycle including development, validation, and transfer
Practical understanding of common QC procedures, techniques, and laboratory equipment/instrumentation and the application and interpretation of most-relevant GMP concepts and compendia requirements (e.g. US FDA, CFR, USP, EP, JP)
Knowledge of Microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin
Knowledge of common QC and environmental monitoring procedures and techniques
Strong background and demonstrated effectiveness in quality assurance operation and compliance of Clinical and commercial Quality laboratory operations
Knowledge of US, EU and rest-of-world cGMP regulations and guidance
Knowledge and proven experience in FDA, EMA, or other regulatory authority
Demonstrated leadership, interpersonal, communication, and motivation skills
Excellent writing and oral communication skills are required
Previous work responsibility, which required a high degree of attention to detail
Well-practiced in exercising sound judgment in decision-making
Demonstrated prioritization and organization skills
Preferred
Quality Assurance experience would be considered beneficial
Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired
Equivalent combination of education and experience acceptable
Benefits
Medical, pharmacy, dental and vision care.
Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 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 and an annual Global Shutdown between Christmas and New Years Day.
Adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Tuition reimbursement and a recognition program.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-09
2026-01-08
2026-01-07
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