Role Description Reporting to the Director, Supplier Quality, the Senior Manager, GxP Audit Program is responsible for oversight and management of the external supplier audit program across GMP, GCP, GLP, and GVP (GxP) domains. The role ensures audits are planned, executed, and managed in a consistent, risk-based, inspection-ready, and business-aligned manner in accordance with global regulatory expectations. You will serve as the central point for audit program governance, including: - Audit planning - Auditor qualification and competency - Observation management - Risk communication - Continuous improvement Working collaboratively with stakeholders, SMEs, and suppliers, the role strengthens audit quality, consistency, and risk focus across the global supplier network. A solution-oriented and forward-thinking mindset is required to proactively identify gaps, optimize resources, and drive continuous improvement initiatives. You will lead the harmonization of the audit program across all GxP areas by establishing aligned scope, regulatory frameworks, and scalable operational structures. 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. - Lead structured audit planning and debriefing strategy and risk prioritization by reviewing supplier performance data. - Standardize audit tools, checklists, and risk models across regions and GxP domains. - Establish and maintain centralized oversight of supplier audit observations across all GxP areas. - 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 and auditors. - Support regulatory inspections by providing audit documentation, risk assessments, and supplier oversight evidence. - Conduct audits with a diplomatic and professional approach. Qualifications - Minimum of a Bachelor of Science in Pharmacy, Chemistry, Engineering, Life Sciences, or related discipline. - 12 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. - Quality Fundamentals: 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 audits 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 and annual equity awards. - Company Learning Institute providing access to LinkedIn Learning and skill-building workshops. - Employee resource groups, service and recognition programs, and meaningful opportunities to connect. Company Description 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.