Bristol Myers Squibb · 1 day ago
Senior Specialist QA Operations
Indianapolis, IN
Full-time
Onsite
Senior Level
$82K/yr - $100K/yr
5+ years expBristol Myers Squibb is a dynamic biotechnology company focused on improving survival of people with cancer. The Senior Specialist, QA Operations will provide quality oversight and ensure compliance in operations at a Radiopharmaceutical facility, supporting clinical development and GMP commercial operations.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Build and maintain cross functional relationships to improve processes and resolve issues
Provide quality oversight on manufacturing and validation activities
Perform real time review of manufacturing records
Perform periodic walkthroughs of manufacturing and Quality Control areas to ensure continued compliance with procedures
Provide guidance on the handling of quality and shop floor activities
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations
Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation
Identify and report discrepancies from required work practices or procedures to management
Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate
Participate as requested in the response team for audits and inspections by health authorities
Qualification
Required
BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred
Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry or a related industry
Experience working in a GMP aseptic manufacturing environment preferred
Experience working with FDA or other regulatory authorities is preferred
Expertise in GMP, Quality, material and product disposition
Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles
Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management
Team player who can work independently to achieve objectives in a fast-paced environment
Excellent verbal and written communication skills
Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired
Knowledge of US, EU and rest-of-world cGMP regulations and guidance
Knowledge and proven experience in FDA, EMA, or other regulatory authority
Well-practiced in exercising sound judgment in decision-making
Demonstrated prioritization and organization skills
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.
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
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.
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
2026-01-08
2026-01-07
2026-01-07
Company data provided by crunchbase