[Hiring] Manager, GxP Audit Program @Insmed Incorporated

Role Description

Reporting to the Director, Supplier Quality, the GxP Audit Program Manager is responsible for oversight and management of the external supplier audit program across GMP, GCP, GLP, and GVP (GxPs) domains. This role ensures audits are planned, executed, and managed in a consistent, risk-based, and inspection-ready manner in alignment with applicable regulatory expectations.

The position serves as the central point for audit program governance, including:

• Audit planning
• Auditor competency and qualification
• Observation management
• Continuous improvement

This role will also lead harmonization of the audit program across all GxP areas by establishing scope, regulatory frameworks, and operational structures required to scale audit oversight effectively.

What You'll Do

• Develop and manage a global, risk-based supplier audit program across GxPs.
• Establish and standardize audit governance, procedures, and processes.
• Lead structured audit planning and debriefing strategy and risk prioritization.
• Standardize audit tools, checklists, and risk models across regions and GxP domains.
• Establish and maintain centralized oversight of supplier audit observations.
• Drive consistency in supplier CAPA evaluation, closure timelines, and effectiveness verification.
• Lead the auditor competency program across GxPs.
• Identify training gaps and implement targeted development plans.
• Lead peer reviews of audit reports and collaborate with subject matter experts.
• Support regulatory inspections by providing audit documentation and risk assessments.
• Conduct audits with a diplomatic and professional approach.

Qualifications

• Minimum of a Bachelor of Science in Pharmacy, Chemistry, Engineering, Life Sciences, or related discipline.
• 10 years of progressive Quality Assurance experience within pharmaceutical, biotechnology, or medical device industries.
• Minimum 5 years of direct experience conducting and leading external supplier audits.
• Demonstrated experience managing or coordinating audit programs across multiple regions and regulatory frameworks.
• Experience supporting Health Authority inspections involving supplier oversight.
• Broad GxP Familiarity: Supporting knowledge of related frameworks such as GDP, GVP, or GLP.
• Deep understanding of ICH guidelines, data integrity principles, and risk management methodologies.
• Excellent technical writing, communication, negotiation, and stakeholder influence skills.

Requirements

• Demonstrated ability to independently plan and execute audit plans across multiple supplier types.
• Assess complex quality systems, identify compliance gaps, evaluate corrective and preventive actions.
• Apply sound risk-based decision making supported by strong analytical and data proficiency.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Generous paid time off policies, fertility and family-forming benefits, caregiver support.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• Company Learning Institute providing access to LinkedIn Learning and skill-building workshops.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect and volunteer.

Where You’ll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.

Travel Requirements

This position involves frequent domestic and international travel up to 20% and exposure to manufacturing, laboratory, and warehouse environments during audits.

Pay Range

$124,000.00-161,000.00 Annual

Life at Insmed

At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it.