Senior Manager - QA Operations
Bristol Myers Squibb
June 26, 2026
On-site
Indianapolis, IN
Operations
Key Responsibilities
- Provide leadership for routine Operations Quality oversight and collaborative triage of unexpected events across Manufacturing, Quality Control Labs, and Supply Chain.
- Apply comprehensive knowledge of Radio-Pharma manufacturing processes for real-time decision-making.
- Synthesize information from multiple sources, interpret problems, and communicate clearly with cross-functional management.
- Respond to complex/critical issues; build consensus with subject-matter experts to justify stopping/continuing manufacturing.
- Serve as a subject-matter expert for the quality management system (deviations/CAPA, interim production controls, disposition decisions, batch record management).
- Evaluate, author, and/or review operating procedures (policies, SOPs, WIs).
- Provide direction for handling/resolution of cGMP events (deviations, batch record exceptions).
- Oversee QA “on-the-floor” systems to ensure timely delivery of QA cGMP tasks.
- Develop standard-work balancing on-floor support, routine QA, and stretch/development projects.
- Assist with quality KPI/metrics for GxP and management reviews.
- Establish/expand/maintain GMP compliance program and build quality culture at the Indianapolis site.
- Proactively identify and address quality risks; lead walkthroughs and review investigation conclusions; approve deviation records.
- Coach/mentor operators and Field QA specialists; interview/hire/lead performance for up to 8 direct reports.
- Apply AI to improve execution and decision-making.
Qualifications & Experience
- Bachelor’s in STEM preferred; High school/Associates may be considered with equivalent education/work.
- 10+ years relevant cGMP experience; preferably 5+ years in QA shop floor and/or QA operations.
- Experience with quality management systems (change control, complaints, deviations, investigations, CAPA).
- Experience in aseptic/sterile environments and/or microbial controls/contamination mitigation preferred.
- FDA/EMA regulations experience in biopharmaceuticals/cell-gene therapy/radio-pharma required.
- Experience with GxP electronic systems (MES for electronic batch records; ERP such as SAP; LIMS; TrackWise/Veeva or similar).
- Ability to interpret complex data, present technical data, lead in fast-paced environments, negotiate/influence, and think strategically with strong decision-making.
Working Conditions
- GMP cleanroom environment; protective clothing and radioactive material handling; able to gown for ISO 8/ISO 7 rooms.
- May require travel up to 20% and occasional lifting up to 30 lbs.
- Provide leadership for routine Operations Quality oversight and collaborative triage of unexpected events across Manufacturing, Quality Control Labs, and Supply Chain.
- Apply comprehensive knowledge of Radio-Pharma manufacturing processes for real-time decision-making.
- Synthesize information from multiple sources, interpret problems, and communicate clearly with cross-functional management.
- Respond to complex/critical issues; build consensus with subject-matter experts to justify stopping/continuing manufacturing.
- Serve as a subject-matter expert for the quality management system (deviations/CAPA, interim production controls, disposition decisions, batch record management).
- Evaluate, author, and/or review operating procedures (policies, SOPs, WIs).
- Provide direction for handling/resolution of cGMP events (deviations, batch record exceptions).
- Oversee QA “on-the-floor” systems to ensure timely delivery of QA cGMP tasks.
- Develop standard-work balancing on-floor support, routine QA, and stretch/development projects.
- Assist with quality KPI/metrics for GxP and management reviews.
- Establish/expand/maintain GMP compliance program and build quality culture at the Indianapolis site.
- Proactively identify and address quality risks; lead walkthroughs and review investigation conclusions; approve deviation records.
- Coach/mentor operators and Field QA specialists; interview/hire/lead performance for up to 8 direct reports.
- Apply AI to improve execution and decision-making.
Qualifications & Experience
- Bachelor’s in STEM preferred; High school/Associates may be considered with equivalent education/work.
- 10+ years relevant cGMP experience; preferably 5+ years in QA shop floor and/or QA operations.
- Experience with quality management systems (change control, complaints, deviations, investigations, CAPA).
- Experience in aseptic/sterile environments and/or microbial controls/contamination mitigation preferred.
- FDA/EMA regulations experience in biopharmaceuticals/cell-gene therapy/radio-pharma required.
- Experience with GxP electronic systems (MES for electronic batch records; ERP such as SAP; LIMS; TrackWise/Veeva or similar).
- Ability to interpret complex data, present technical data, lead in fast-paced environments, negotiate/influence, and think strategically with strong decision-making.
Working Conditions
- GMP cleanroom environment; protective clothing and radioactive material handling; able to gown for ISO 8/ISO 7 rooms.
- May require travel up to 20% and occasional lifting up to 30 lbs.