Senior Manager, GxP Audit Program

Insmed Incorporated•NJ Corporate Headquarters, NJ

3d•$124,000 - $161,000•Remote

About The Position

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 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. Leveraging broad industry experience and cross GxP knowledge, the position supports independent decision making, risk escalation, and oversight of complex supplier networks supporting clinical and commercial operations. You will serve as the central point for audit program governance, including audit planning, auditor qualification and competency, observation management, risk communication, and 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. This role is expected to demonstrate strong ownership, mentor and support auditors, and participate in audit execution when needed. The role requires recognized expertise in at least one GxP area, working knowledge across other GxP disciplines, and the ability to engage SMEs to resolve complex compliance and quality matters.

Requirements

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 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
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back