Manager, GxP Audit Program

Insmed Incorporated

2d • Remote

About The Position

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, and continuous improvement. In addition to supporting audit execution, this role is accountable for strengthening audit quality, consistency, and risk focus across a diverse global supplier network supporting clinical and commercial operations. 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.

Requirements

• Minimum of a Bachelor of Science in Pharmacy, Chemistry, Engineering, Life Sciences, or related discipline as well as 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 including CMOs, CROs, laboratories, and distribution partners.
• Experience supporting Health Authority inspections involving supplier oversight.
• GMP (21 CFR Parts 210/211, 820, and EudraLex Vol 4) or GCP (21 CFR Parts 50, 56, 312, Clinical Trials Regulation (EU) No 536/2014, and ICH E6 (R3).
• Broad GxP Familiarity: Supporting knowledge of related frameworks such as GDP, GVP, or GLP.
• Quality Fundamentals: Deep understanding of ICH guidelines, data integrity principles, and risk management methodologies.
• Demonstrated ability to independently plan and execute audits plans across multiple supplier types, assess complex quality systems, identify compliance gaps, evaluate corrective and preventive actions, and apply sound risk-based decision making supported by strong analytical and data proficiency.
• Excellent technical writing, communication, negotiation, and stakeholder influence skills, with the ability to collaborate cross functionally at all levels, maintain audit integrity and objectivity, manage variable workloads and projects, and engage effectively with senior management.

Nice To Haves

• ASQ Certified Quality Auditor, IRCA Lead Auditor certification, or equivalent credential.

Responsibilities

• Develop and manage a global, risk-based supplier audit program across GxPs including defining audit strategy and annual plans based on supplier criticality, risk classification, and regulatory expectations.
• Establish and standardize audit governance, procedures, and processes to ensure consistent planning, execution, reporting, and follow up, while maintaining alignment with applicable regulations including 21 CFR Parts 210, 211, and 820, EU GMP (EudraLex Volume 4), EU GDP, ICH guidelines, GCP, GLP, and GVP requirements.
• Lead structured audit planning and debriefing strategy and risk prioritization by reviewing supplier performance data, including deviations, CAPAs, complaints, change notifications, prior audit outcomes, and regulatory inspection history, to ensure audits are focused on high-risk areas and emerging compliance trends.
• Standardize audit tools, checklists, and risk models across regions and GxP domains, incorporating regulatory intelligence and cross functional input to drive consistent and effective audit execution.
• Establish and maintain centralized oversight of supplier audit observations across all GxP areas, partnering with lead auditors and subject matter experts to ensure consistent classification based on risk and regulatory impact.
• Drive consistency in supplier CAPA evaluation, closure timelines, and effectiveness verification, while monitoring audit trends to identify systemic risks and recurring compliance issues across the supplier base.
• Lead the auditor competency program across GxPs by assessing auditor qualifications, experience, and technical expertise, and maintaining a capability matrix that captures audit history, domain knowledge, and regional regulatory expertise.
• Identify training gaps and implement targeted development plans to strengthen auditor effectiveness and consistency, ensuring auditors maintain appropriate qualifications and certifications aligned with industry expectations.
• Lead peer reviews of audit reports and collaborate with subject matter experts and auditors to ensure outputs are objective, evidence based, and aligned with applicable regulatory standards.
• Ensure findings are documented clearly and consistently, while maintaining independence and integrity throughout all stages of audit execution and reporting.
• Support regulatory inspections by providing audit documentation, risk assessments, and supplier oversight evidence.
• Maintain audit records, metrics, and dashboards to demonstrate program effectiveness.
• Conduct audits with a diplomatic and professional approach, communicating observations clearly and respectfully while maintaining firm adherence to GxP requirements.
• Lead discussions with supplier personnel in a manner that promotes transparency, accountability, and constructive resolution of compliance gaps.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Manager