Description

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 four 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:
The Associate Director, Quality Control will be responsible for leading and overseeing all Quality Control activities related to inhalation products, including both Active Pharmaceutical Ingredients (API) and Drug Product.

This role will manage external QC laboratories to ensure the timely and compliant execution of release, stability, and in-process testing in accordance with cGMP, regulatory requirements, and company quality standards. The successful candidate will provide strategic and technical oversight for laboratory operations, including routine testing, data review, investigations, and documentation. The individual will work collaboratively with cross-functional teams to ensure seamless execution of QC deliverables in support of clinical and commercial programs. A key aspect of this role involves managing contract testing organizations (CTOs) to ensure performance, compliance, and timely execution of testing activities. Core responsibilities include maintaining regulatory compliance, ensuring data integrity, and driving operational excellence within QC functions. A deep understanding of GMP, quality control processes, and analytical testing for inhalation products is essential, along with proven leadership experience in a dynamic, regulated environment.

What You'll Do:

• Provide oversight and technical direction for all Quality Control activities conducted at external laboratories (CTOs and contract partners) related to inhalation products, including API and Drug Product testing for release, stability, and in-process control.
• Ensure external labs operate in full compliance with cGMP, regulatory expectations, and Insmed quality standards. Support inspection readiness and provide QC-related documentation and responses during regulatory inspections and audits.
• Review and approve analytical method execution, instrument qualification records, and data packages generated by external labs, with small molecule projects and particular focus on inhalation-specific testing (e.g., APSD, MMAD, delivered dose, particle size distribution).
• Lead and approve deviation investigations, OOS, and OOT results generated by external labs. Ensure thorough root cause analysis and appropriate CAPA implementation.
• Ensure external laboratory documentation-including CoAs, test methods, protocols, and reports-meets Insmed's data integrity standards and regulatory requirements. Review and approve external lab records as part of batch disposition process.
• Review and support the development of product specifications and justification documents across the lifecycle of inhalation products. Ensure alignment with regulatory guidance and clinical/commercial phase requirements.
• Contribute QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC data or practices from external labs.
• Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other departments to ensure external QC activities align with project timelines and product lifecycle needs.
• Establish quality and delivery KPIs for contract labs. Routinely assess performance, resolve issues, and ensure timely completion of all QC testing and reporting deliverables.
• Manage multiple external QC workstreams across development and commercial programs under tight timelines. Proactively identify risks, escalate concerns, and drive resolutions efficiently.
• Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.
• Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.

Who You Are:

• Bachelor's degree in chemistry, Biochemistry, or related discipline with 10+ years of experience, or MS with 8+ years of experience or PhD with 5+ years of experience in the pharmaceutical industry, specifically Quality control department with at least 5 years in Quality Control roles involving oversight of external testing laboratories.
• Hands-on expertise in analytical lab testing for inhalation dosage forms and other small molecule dosage forms. Experience with inhalation and combination products is preferred.
• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
• Excellent analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management.
• Effective communication skills, both verbal and written, including experience drafting regulatory responses and QC sections of submissions.
• Strong organizational and project management skills, with a focus on timeliness, quality, and compliance.
• Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment. Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Travel:

• This position requires up to 10% travel

Pay Range:
$139,000.00-195,200.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and 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, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

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 TotalRewards@insmed.com 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.