Manager, GMP Inspection Management
Bristol Myers Squibb
6 hours ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Provide management of Site Quality Operations in accordance with RayzeBio policies, standards, procedures, and global cGMPs.
- Lead site inspection readiness efforts to prepare the Indianapolis site for health authority inspections and internal corporate audits.
- Develop and manage an Inspection Readiness annual plan, including identification of anticipated inspections.
- Participate in corporate and health authority inspections; lead cross-functional teams to develop responses and track commitments to completion.
- Own and manage the RayzeBio Self-Inspection Program, including conducting audits of departments relative to RayzeBio policies/procedures and Health Authority requirements.
- Lead Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments, and developing proactive action plans.
- Provide compliance expertise and guidance on applicable regulatory, cGMP, and corporate requirements.
- Support regulatory agency correspondence and filing/submission activities.
- Lead fact finding deliverables for significant events and support Field Alert Reporting submissions as required.
- Lead APQR document coordination and provide authoring support for the site.
- Identify and report discrepancies from required work practices/procedures to management.
- Exercise sound judgment within defined practices/policies and notify management as appropriate.
- Provide oversight to implement changes that support long-term department and company goals.
- Perform other QA responsibilities as assigned.
Qualifications:
- Bachelor’s degree in engineering or a life/physical science (including biology, biochemistry, chemistry) required.
- 5–7 years of Quality Assurance experience required.
- Minimum 4 years of direct QA experience leading/hosting/conducting GMP audits/inspections required.
- Strong background in quality assurance operations and compliance of clinical/commercial manufacturing (desired).
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Proven experience hosting/facilitating FDA, EMA, or other regulatory authority inspections.
Required skills:
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills.
- High attention to detail.
- Sound judgment in decision-making.
- Strong prioritization and organization skills.
Work conditions:
- Laboratory environment with protective clothing, gloves, safety glasses; may involve radioactive materials.
- Occasional travel up to 5%.
Compensation/benefits (as stated):
- Indianapolis: $124,449–$150,803 starting compensation range (FTE). Additional incentive cash/stock may be available (eligibility-dependent).
- Provide management of Site Quality Operations in accordance with RayzeBio policies, standards, procedures, and global cGMPs.
- Lead site inspection readiness efforts to prepare the Indianapolis site for health authority inspections and internal corporate audits.
- Develop and manage an Inspection Readiness annual plan, including identification of anticipated inspections.
- Participate in corporate and health authority inspections; lead cross-functional teams to develop responses and track commitments to completion.
- Own and manage the RayzeBio Self-Inspection Program, including conducting audits of departments relative to RayzeBio policies/procedures and Health Authority requirements.
- Lead Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments, and developing proactive action plans.
- Provide compliance expertise and guidance on applicable regulatory, cGMP, and corporate requirements.
- Support regulatory agency correspondence and filing/submission activities.
- Lead fact finding deliverables for significant events and support Field Alert Reporting submissions as required.
- Lead APQR document coordination and provide authoring support for the site.
- Identify and report discrepancies from required work practices/procedures to management.
- Exercise sound judgment within defined practices/policies and notify management as appropriate.
- Provide oversight to implement changes that support long-term department and company goals.
- Perform other QA responsibilities as assigned.
Qualifications:
- Bachelor’s degree in engineering or a life/physical science (including biology, biochemistry, chemistry) required.
- 5–7 years of Quality Assurance experience required.
- Minimum 4 years of direct QA experience leading/hosting/conducting GMP audits/inspections required.
- Strong background in quality assurance operations and compliance of clinical/commercial manufacturing (desired).
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Proven experience hosting/facilitating FDA, EMA, or other regulatory authority inspections.
Required skills:
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills.
- High attention to detail.
- Sound judgment in decision-making.
- Strong prioritization and organization skills.
Work conditions:
- Laboratory environment with protective clothing, gloves, safety glasses; may involve radioactive materials.
- Occasional travel up to 5%.
Compensation/benefits (as stated):
- Indianapolis: $124,449–$150,803 starting compensation range (FTE). Additional incentive cash/stock may be available (eligibility-dependent).