Manager, GMP Inspection Management
Bristol Myers Squibb
5 months ago
On-site
Indianapolis, IN
Operations
Summary
The Manager, GMP Inspection Management provides management of Site Quality Operations activities in accordance with RayzeBio policies/standards/procedures and global cGMPs. Own the Self-Inspection Program, Pre-Licensure Inspection Readiness Audits, QP audits, and Health Authority Inspections.
Job Responsibilities
- Lead site inspection readiness efforts for Indianapolis for health authority inspections and internal corporate audits.
- Develop and manage the Inspection Readiness annual plan (identify anticipated inspections).
- Participate in corporate/health authority inspections; lead cross-functional response teams and track commitments to completion.
- Own the RayzeBio Self-Inspection Program; conduct audits of departments vs. RayzeBio policies/procedures and Health Authority requirements.
- Lead Regulatory Surveillance (identify impacted functions, drive impact assessments, and proactive action plans).
- Provide compliance expertise/guidance on regulatory, cGMP, and corporate requirements.
- Support regulatory agency correspondence and filing submissions.
- Lead fact-finding deliverables for significant events and support Field Alert Reporting.
- Lead APQR document coordination/authoring support for site.
- Identify/report discrepancies; make sound decisions with appropriate management notification.
Education and Experience / Required Skills
- Bachelor’s degree in engineering or life/physical sciences (biology, biochemistry, chemistry).
- 5–7 years QA experience; 4+ years direct QA experience leading/hosting/conducting GMP audits/inspections.
- Knowledge of US/EU and rest-of-world cGMPs.
- Proven experience hosting/facilitating FDA/EMA/other authority inspections.
- Strong leadership, interpersonal, communication, motivation; excellent writing/oral communication; attention to detail; sound judgment; prioritization/organization.
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs (incl. EAP).
- Financial protection (401(k), disability, life/accident/supplemental insurance, etc.).
- Paid time off (flexible time off or annual paid vacation depending on role/location/eligibility).
Job ID
R1600119 Manager, GMP Inspection Management
The Manager, GMP Inspection Management provides management of Site Quality Operations activities in accordance with RayzeBio policies/standards/procedures and global cGMPs. Own the Self-Inspection Program, Pre-Licensure Inspection Readiness Audits, QP audits, and Health Authority Inspections.
Job Responsibilities
- Lead site inspection readiness efforts for Indianapolis for health authority inspections and internal corporate audits.
- Develop and manage the Inspection Readiness annual plan (identify anticipated inspections).
- Participate in corporate/health authority inspections; lead cross-functional response teams and track commitments to completion.
- Own the RayzeBio Self-Inspection Program; conduct audits of departments vs. RayzeBio policies/procedures and Health Authority requirements.
- Lead Regulatory Surveillance (identify impacted functions, drive impact assessments, and proactive action plans).
- Provide compliance expertise/guidance on regulatory, cGMP, and corporate requirements.
- Support regulatory agency correspondence and filing submissions.
- Lead fact-finding deliverables for significant events and support Field Alert Reporting.
- Lead APQR document coordination/authoring support for site.
- Identify/report discrepancies; make sound decisions with appropriate management notification.
Education and Experience / Required Skills
- Bachelor’s degree in engineering or life/physical sciences (biology, biochemistry, chemistry).
- 5–7 years QA experience; 4+ years direct QA experience leading/hosting/conducting GMP audits/inspections.
- Knowledge of US/EU and rest-of-world cGMPs.
- Proven experience hosting/facilitating FDA/EMA/other authority inspections.
- Strong leadership, interpersonal, communication, motivation; excellent writing/oral communication; attention to detail; sound judgment; prioritization/organization.
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision).
- Wellbeing support programs (incl. EAP).
- Financial protection (401(k), disability, life/accident/supplemental insurance, etc.).
- Paid time off (flexible time off or annual paid vacation depending on role/location/eligibility).
Job ID
R1600119 Manager, GMP Inspection Management