Sr Director, Quality Assurance - CMC

Insmed Inc. • Bridgewater, NJ • 15h ago

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2025, we became Great Place to Work-certified in the U.S. for the fifth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists. Overview The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. Responsibilities Responsibilities: Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards. Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies. Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports. Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs. Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance. Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up. Drive phase-appropriate quality system improvements for development-stage programs. Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy. Lead and develop a team of 2-8 Quality professionals supporting development programs; provide coaching, feedback, and career growth opportunities. Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation. Create, maintain, and enhance Standard Operating Procedures governing Development QA activities. * Support investigations and root caus

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