Manager, QA Compliance
Bristol Myers Squibb
3 days ago
On-site
Indianapolis, IN
Operations
Job Responsibilities:
- Implement and manage the Change Control Quality System for all GMP activities; ensure timely cross-functional completion.
- Run Change Control Review Boards, generate minutes, track actions, and facilitate resolution.
- Communicate with cross-functional stakeholders on change control.
- Implement/manage investigations and CAPA review boards.
- Lead the site Quality Council program.
- Develop and maintain Quality Metrics to monitor compliance.
- Collaborate to address quality system issues.
- Lead the site Data Integrity Program.
- Manage complaints.
- Participate in corporate/health authority inspections.
- Identify/report discrepancies to management.
- Make sound decisions within defined practices/policies and notify management as appropriate.
- Lead teams and cross-functional project teams; drive performance and quality initiatives.
- Perform other QA responsibilities as assigned.
- Apply AI to improve execution and decision-making.
Qualifications / Education & Experience:
- Bachelor’s degree in engineering or life/physical science (biology, biochemistry, chemistry) (required).
- Minimum 5 years of Quality Assurance experience (required).
- Strong QA operations/compliance experience in clinical/commercial manufacturing (desired).
- Knowledge of US/EU and other cGMP regulations/guidance.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication.
- High attention to detail; sound judgment; prioritization/organization.
Compensation & Benefits (as stated):
- Health coverage; wellbeing support programs; 401(k), disability, life/accident insurance, supplemental health, travel protection, legal support, survivor support.
- Paid time off and holidays (details vary by location/employee type).
- Implement and manage the Change Control Quality System for all GMP activities; ensure timely cross-functional completion.
- Run Change Control Review Boards, generate minutes, track actions, and facilitate resolution.
- Communicate with cross-functional stakeholders on change control.
- Implement/manage investigations and CAPA review boards.
- Lead the site Quality Council program.
- Develop and maintain Quality Metrics to monitor compliance.
- Collaborate to address quality system issues.
- Lead the site Data Integrity Program.
- Manage complaints.
- Participate in corporate/health authority inspections.
- Identify/report discrepancies to management.
- Make sound decisions within defined practices/policies and notify management as appropriate.
- Lead teams and cross-functional project teams; drive performance and quality initiatives.
- Perform other QA responsibilities as assigned.
- Apply AI to improve execution and decision-making.
Qualifications / Education & Experience:
- Bachelor’s degree in engineering or life/physical science (biology, biochemistry, chemistry) (required).
- Minimum 5 years of Quality Assurance experience (required).
- Strong QA operations/compliance experience in clinical/commercial manufacturing (desired).
- Knowledge of US/EU and other cGMP regulations/guidance.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication.
- High attention to detail; sound judgment; prioritization/organization.
Compensation & Benefits (as stated):
- Health coverage; wellbeing support programs; 401(k), disability, life/accident insurance, supplemental health, travel protection, legal support, survivor support.
- Paid time off and holidays (details vary by location/employee type).