Associate Director, Clinical Quality Assurance

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 of Clinical Quality Assurance, the Associate Director of Clinical Quality Assurance (CQA) - Japan & APAC serves as a CQA lead representative on the development team assuring quality and regulatory compliance related to GCPs and other related activities performed by Medical/Clinical Departments in Japan and Asia-Pacific (APAC) region. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines. What You'll Do: Japan & APAC GCP Subject Matter Expert (SME). Contribute to and support the maintenance of a risk-based and scientific-based quality system to support GCP. Ensure that a strategic audit plan is implemented. That the activities are conducted and reported according to SOPs and regulations. Perform audits of investigator sites, vendors, and internal systems/processes. Support the evaluation and acceptability of vendors for potential use and provide direction, guidance and strategy for company Quality and Compliance. Support strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues. Establish and foster compliance with ICH E6 Guideline for Good Clinical Practice. Provide support and coaching to other staff members to develop additional quality and auditing resources. Manage regional quality documentation in Veeva QMS and Vault. Act as company’s representative during regulatory agency inspections. Who You Are: Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 7-10 years of experience. Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered. Experience in effectively managing regulatory agency inspections and working with regulators and internal staff to help prepare for inspections is required. An understanding of regulations, development processes and regulatory inspection procedures is required. Experience developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential. GCP audit experience is required including ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs. Ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs. Must demonstrate practical working knowledge of GCP regulations. Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice. Requires solid experience with Phases I-IV (particularly Phase III); experience with Regulatory approval, NDAs and MAAs is preferred. Must be able to foster a collaborative/partnership environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building while maintaining quality and compliance. Highly organized with a strong attention to detail, cla ... (truncated, view full listing at source)