Senior Manager, GxP Audit Program
Insmed Incorporated
3 hours ago
Remote
United States
Operations
Senior Manager, GxP Audit Program (Remote)
Responsibilities:
- Oversee and manage the external supplier audit program across GMP, GCP, GLP, and GVP in a risk-based, inspection-ready, and business-aligned manner.
- Govern audit program execution: audit planning, auditor qualification/competency, observation management, risk communication, and continuous improvement.
- Harmonize the audit program across GxP areas by aligning scope, regulatory frameworks, and scalable operations; mentor auditors and support execution as needed.
- Lead governance and standardization of procedures, tools/checklists, risk models, observation classification, CAPA evaluation/closure/effectiveness verification.
- Develop a global, risk-based annual audit strategy based on supplier criticality and regulatory expectations.
- Conduct peer reviews of audit reports; support regulatory inspections with documentation and evidence.
Qualifications / Required:
- BS in Pharmacy, Chemistry, Engineering, Life Sciences, or related; 12+ years progressive Quality Assurance experience in pharma/biotech/medical devices.
- 5+ years leading external supplier audits.
- Experience coordinating audits across regions/regulatory frameworks (e.g., CMOs, CROs, labs, distribution partners).
- Experience supporting Health Authority inspections.
- GMP and/or GCP knowledge (including 21 CFR, EudraLex Vol 4, ICH E6 R3 as applicable); broad GxP familiarity (GDP/GVP/GLP).
- Strong understanding of ICH, data integrity, and risk management; excellent communication/technical writing.
Nice to have:
- ASQ Certified Quality Auditor or IRCA Lead Auditor (or equivalent).
Benefits (U.S. highlights): medical/dental/vision, mental health support/EAP, paid time off, 401(k) match, equity/ESPP, learning programs.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities:
- Oversee and manage the external supplier audit program across GMP, GCP, GLP, and GVP in a risk-based, inspection-ready, and business-aligned manner.
- Govern audit program execution: audit planning, auditor qualification/competency, observation management, risk communication, and continuous improvement.
- Harmonize the audit program across GxP areas by aligning scope, regulatory frameworks, and scalable operations; mentor auditors and support execution as needed.
- Lead governance and standardization of procedures, tools/checklists, risk models, observation classification, CAPA evaluation/closure/effectiveness verification.
- Develop a global, risk-based annual audit strategy based on supplier criticality and regulatory expectations.
- Conduct peer reviews of audit reports; support regulatory inspections with documentation and evidence.
Qualifications / Required:
- BS in Pharmacy, Chemistry, Engineering, Life Sciences, or related; 12+ years progressive Quality Assurance experience in pharma/biotech/medical devices.
- 5+ years leading external supplier audits.
- Experience coordinating audits across regions/regulatory frameworks (e.g., CMOs, CROs, labs, distribution partners).
- Experience supporting Health Authority inspections.
- GMP and/or GCP knowledge (including 21 CFR, EudraLex Vol 4, ICH E6 R3 as applicable); broad GxP familiarity (GDP/GVP/GLP).
- Strong understanding of ICH, data integrity, and risk management; excellent communication/technical writing.
Nice to have:
- ASQ Certified Quality Auditor or IRCA Lead Auditor (or equivalent).
Benefits (U.S. highlights): medical/dental/vision, mental health support/EAP, paid time off, 401(k) match, equity/ESPP, learning programs.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.