Manager, GMP Inspection Management
Bristol Myers Squibb
6 hours ago
On-site
Indianapolis, IN
Operations
Summary
The Manager, GMP Inspection Management provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs. Responsible for the Self-Inspection Program, Pre-Licensure Inspection Readiness Audits, QP audits, and Health Authority Inspections.
Responsibilities
- Lead site inspection readiness efforts for the Indianapolis site for health authority inspections and internal corporate audits.
- Develop and manage the Inspection Readiness annual plan, including identification of anticipated inspections.
- Participate as a core team member in corporate/health authority inspections; lead cross-functional teams to develop responses and track commitments to completion.
- Responsible for the RayzeBio Self-Inspection Program; may conduct audits of RayzeBio departments relative to RayzeBio policies/procedures and relevant Health Authority requirements.
- Lead Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments, and proactive action plans.
- Provide compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements.
- Support regulatory agency correspondence and filing submission activities.
- Lead Fact Finding deliverables for significant events; support Field Alert Reporting submissions as required.
- Lead APQR document coordination and authoring support for the site.
- Identify and report discrepancies from required work practices or procedures to management.
- Make sound decisions using judgment within defined practices/policies and notify management as appropriate.
- Provide oversight to identify and implement changes that support long-term department and company goals.
- Other QA responsibilities as assigned.
Qualifications (Education/Experience)
- Bachelor’s degree in engineering or a life/physical science field (including biology, biochemistry, chemistry) required.
- 5–7 years in Quality Assurance required; minimum 4 years of direct QA experience leading/hosting/conducting GMP audits/inspections.
- Strong background in quality assurance operations and compliance for clinical/commercial manufacturing (desired).
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Knowledge/proven experience hosting/facilitating FDA, EMA, or other regulatory authority inspections.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills required.
- Strong attention to detail.
- Sound judgment in decision-making.
- Prioritization and organization skills.
Benefits (as stated)
- Health Coverage: medical, pharmacy, dental, and vision care.
- Wellbeing support programs (e.g., Well-Being Account, Living Life Better, EAP).
- Financial well-being and protection (401(k), disability, life/accident insurance, supplemental health, etc.).
- Paid Time Off (including flexible time off/vacation and paid national holidays, based on employee category).
Work/Physical Requirements (as stated)
- Laboratory environment with protective clothing, gloves, and safety glasses; may involve radioactive materials.
- Occasional lifting/moving up to 25 pounds; close and distance vision required.
- Occasional travel, not more than 5%.
Application Instructions (as stated)
- Job Title/Requisition: R1600119 Manager, GMP Inspection Management.
The Manager, GMP Inspection Management provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs. Responsible for the Self-Inspection Program, Pre-Licensure Inspection Readiness Audits, QP audits, and Health Authority Inspections.
Responsibilities
- Lead site inspection readiness efforts for the Indianapolis site for health authority inspections and internal corporate audits.
- Develop and manage the Inspection Readiness annual plan, including identification of anticipated inspections.
- Participate as a core team member in corporate/health authority inspections; lead cross-functional teams to develop responses and track commitments to completion.
- Responsible for the RayzeBio Self-Inspection Program; may conduct audits of RayzeBio departments relative to RayzeBio policies/procedures and relevant Health Authority requirements.
- Lead Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments, and proactive action plans.
- Provide compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements.
- Support regulatory agency correspondence and filing submission activities.
- Lead Fact Finding deliverables for significant events; support Field Alert Reporting submissions as required.
- Lead APQR document coordination and authoring support for the site.
- Identify and report discrepancies from required work practices or procedures to management.
- Make sound decisions using judgment within defined practices/policies and notify management as appropriate.
- Provide oversight to identify and implement changes that support long-term department and company goals.
- Other QA responsibilities as assigned.
Qualifications (Education/Experience)
- Bachelor’s degree in engineering or a life/physical science field (including biology, biochemistry, chemistry) required.
- 5–7 years in Quality Assurance required; minimum 4 years of direct QA experience leading/hosting/conducting GMP audits/inspections.
- Strong background in quality assurance operations and compliance for clinical/commercial manufacturing (desired).
- Knowledge of US, EU, and rest-of-world cGMP regulations and guidance.
- Knowledge/proven experience hosting/facilitating FDA, EMA, or other regulatory authority inspections.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Excellent writing and oral communication skills required.
- Strong attention to detail.
- Sound judgment in decision-making.
- Prioritization and organization skills.
Benefits (as stated)
- Health Coverage: medical, pharmacy, dental, and vision care.
- Wellbeing support programs (e.g., Well-Being Account, Living Life Better, EAP).
- Financial well-being and protection (401(k), disability, life/accident insurance, supplemental health, etc.).
- Paid Time Off (including flexible time off/vacation and paid national holidays, based on employee category).
Work/Physical Requirements (as stated)
- Laboratory environment with protective clothing, gloves, and safety glasses; may involve radioactive materials.
- Occasional lifting/moving up to 25 pounds; close and distance vision required.
- Occasional travel, not more than 5%.
Application Instructions (as stated)
- Job Title/Requisition: R1600119 Manager, GMP Inspection Management.