Manager, Quality Control

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:
The Manager of Quality Control will serve as a strategic and tactical quality professional in ensuring oversight and execution of all aspects of commercial GMP related analytical testing, as well as late stage GMP development testing. Responsible for ensuring oversight of contract laboratories and testing performed by manufacturers of all commercial and late stage development products, including starting materials, in-process, release, and stability testing throughout the product lifecycle. Accountable for assemble, review and trending the release, IPC, and stability data. This role supports Insmed quality culture through collaborating externally and internally to ensure method transfers, method validation, and QC data integrity is established and maintained for the late phase development and commercial programs.

What You'll Do:

In this role you will lead and assist in identifying changes to the processes and impact on the product quality and established procedures. Additionally, you will review, assemble and trend release, IPC, and stability data, generating reports as necessary.

You'll also:

• Handles contract laboratory vendors, supervises laboratory performance, assesses capability, and ensures actions are taken to improve if needed.
• Point person for weekly communications with external labs for status updates and testing activities.
• Measure performance against established Key Performance Indicators (critical metrics), thereby consistently ensuring timely and accurate testing, reporting, and release.
• Ensures all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and appropriate corrective actions implemented.
• Handle method transfer, method development and validation activities at external lab site
• Cross-functional liaison working closely with internal collaborators.
• Statistical programming and data management support is a plus.
• Develop statistical analysis plans if needed, including the definition of derived data sets and the design of templates for statistical tables, figures, data listings and/or graphs for clinical summary reports.
• Provide mentorship, support and training to internal / external staff as the need arises.

Who You Are:

You have a BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, science program with a minimum of 5+ years in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing

• Knowledge of QC processes and procedures and GMP regulations and mentorship with shown efficiency in maintaining QC processes for compliance with regulations.
• Expertise in method verification and validation procedures.
• Knowledge of Statistical programming preferred.
• Experience of API manufacturing and process chemistry preferred.
• Excellent presentation skills both verbal and written.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Ability to establish and maintain collaborative working relationships with internal and external partners required.
• Ability to take initiative and work independently while optimally handling timelines required.

Where You'll Work

This is a hybrid role based out of our Bridgewater, NJ office . You'll work remotely most of the time, with in-person collaboration when it matters most.

#LI-SK1
#LI-SK - Hybrid

Pay Range:
$124,000.00-161,000.00 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.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

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.