Manager, Quality Control – Stability and Sample Management

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:

We’re looking for a Manager, Quality Control – Stability and Sample Management on the Quality Control team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, QC Operations, you’ll be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy.

What You'll Do:

In this role, you’ll have the opportunity to provide hands-on leadership for the QC Stability and Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.

 You’ll also:

• Provide hands-on leadership for the QC Stability and Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.

• Potentially oversee QC technicians and directly manage individuals (includes goal setting, performance

• feedback, skills development, and mentoring.)

• Manage stability programs, including study initiation and sample pulls for cell banks, starting materials,

• intermediates, drug substances, and drug products.

• Manage reference standard and critical reagent programs, including creation, qualification, and inventory.

• Author GxP stability protocols, interim reports, and reports for stability studies.

• Manage, report, and trend stability data in JMP software and/or Labware LIMS. Escalate out of trend observations and support associated investigations, including: temperature excursion assessments, clientand regulatory requests, and investigational testing. Assist in creating a stability budget for drug product shipments.

• Own and support stability and sample management-related Deviations, CAPAs, and Change Controls.

• Drive related improvements.

• Participate in the deployment and configuration of software systems for stability and sample management (e.g., JMP, Labware LIMS)

• Collaborate with Quality Assurance, Manufacturing and CMOs, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.

• Create, maintain, and revise QC SOPs, and associated documents.

• Manage all aspects of the stability and sample management labs including ordering supplies and maintaining laboratory equipment, stability chambers, and lab spaces and create and maintain all processes around sample chain of custody and locations. Act as the single point of contact to control distribution of all samples for release and stability testing to QC personnel. Ensure access to GxP sample storage devices (release and stability samples) is limited to self and designated back up.

• Support inspection and client audit readiness plans. Serve as subject matter expert for stability and sample management related topics.

• Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management. Capture metric information for use in continuous improvement of areas of responsibility.

• Participate in daily and weekly operation meetings and Quality Management Reviews.

Who You Are:

You have a Bachelor’s degree along with 8 years of experience in the pharmaceutical, or a Master’s degree with minimum 5 years of relevant experience.

You are or you also have:

• Experience in managing GMP stability studies across all phases of drug development.
• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance and drug product stability testing.
• Strong technical writing, attention to detail, organizational, and excellent analytical skills.
• 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 cooperative working relationships with internal and external partners required.
• Ability to take initiative and work independently while effectively managing timelines required.
• Proficiency in Microsoft Office applications and other relevant software tools (i.e., Oracle, Veeva, JMP, BMRAM, and LIMS).

Nice to have (but not required):

• The ideal candidate will have commercial GMP experience in supporting stability and sample management programs.
• Experience with JMP statistical software, Labware LIMS, and Smartsheet a plus

Where You’ll Work

This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

This role requires occasional domestic/international travel (approximately 0–15%)

#LI-Onsite

#LI-BA1

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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

 

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.