Manager, GxP Audit Program

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: 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. What You'll Do: In this role, you'll have the opportunity to 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.  You will also: 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 ... (truncated, view full listing at source)