Insmed

Manager, Quality Control

Research Development Lab - San Diego · Director · Full-time

Sponsorship not specified$124k-$161kDetected 68 days ago

HRGMPFDA RegulatoryCRISPRMass SpectrometryLeadershipCommunicationCollaborationMentoring

About the role

We're looking for a Manager, Quality Control on the Quality Control team to help us expand what's possible for patients with serious diseases.
Reporting to the Associate Director, Quality Control, you'll be responsible for overseeing and performing the testing of HPLC and compendial methods.
Additional responsibilities include, but are not limited to, establishing/qualifying QC test methods, authoring/revising SOP's, and managing quality events.

In this role, you'll have the opportunity to perform and oversee testing of compendial and HPLC, CE-SDS, ICP-MS methods for the product purity group You'll also:
Perform and oversee quality events such as deviation, CAPA, change control, investigation of OOS, OOT and atypical results within the company QMS according to established procedures.
Develop timelines and protocols for assay transfers, qualifications and validations. Support method transfer activities between lab and CDMO's.
Manage QC laboratory, track critical reagents and logbooks, and ensure all the equipment is calibrated
Utilize software to perform routine laboratory activities (Labware LIMS, JMP, Chromeleon, etc.). Participate in implementation of new software and updates as a subject matter expert.
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.

You have a Bachelor's degree along with 7+ years of experience in quality control.
You are or you also have:

Significant experience in an FDA-regulated environment
Experience with direct reports or managing people
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

Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
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
$124,000.00-161,000.00 Annual
Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established.

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
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.

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.

Insmed Incorporated is an Equal Opportunity employer.
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.

This listing is sourced directly from Insmed's careers page and normalized into a canonical job model.