Description

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 cause analysis of product or process issues related to clinical manufacturing.
• Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.
• Responsible for final product Quality release/rejection and related processes.
• Support supplier and internal audits as necessary.
• Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc
• Additional duties as assigned

Position Requirements:

• 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; advanced degree may substitute for years of experience.
• Minimum 7 years of direct GxP experience (GMP, GCP, and/or GLP) in a regulated environment supporting biologics, drug products, or combination products.
• 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.
• Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and vendor management experience.
• Proven expertise in root cause analysis, investigations, change control, and Quality risk management.
• Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
• 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.
• Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
• Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills.
• 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.

Travel - 40% domestic and/or international#LI-JT1 #LI-Hybird

Salary Range

$207,000 - $289,867 a year

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off plans
• Competitive compensation package, including bonus
• Equity Awards (Long-Term Incentives)
• Employee Stock Purchase Plan (ESPP)

For more information on U.S. benefits click here.

Additional Information

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.