Insmed is seeking a Sr. Director CMC QA to lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through Phase 3, ensuring phase-appropriate GMP compliance and providing strategic Quality leadership.
Requirements
- Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development.
- Minimum 7 years of direct GxP experience (GMP, GCP, and/or GLP) in a regulated environment supporting biologics, drug products, or combination products.
- Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
- Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred.
- ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred.
- BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
- Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage programs
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.
- 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.
Other
- BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred.
- Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage programs
- Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment.
- Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels.
- Travel - 40% domestic and/or international
