Insmed

Director, Quality Assurance Systems

Research Development Lab - San Diego · Director

Sponsorship not specified$177k-$242kDetected 74 days ago

AuditingHRGMPFDA RegulatoryCRISPRResearchLeadershipCommunicationCollaborationMentoringOrganizational SkillsGxP

About the role

Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities

In this role, you will lead the implementation, validation, and lifecycle management of GxP digital systems within an FDA-regulated (or equivalent global regulatory) environment supporting Gene Therapy programs.
Provide guidance to team members on software development life cycle, computer validation, and drive a risk-based approach methodology with all stakeholders.
Provide oversight to the implementation and validation of GxP software applications/modules and associated interfaces according to business needs and internal procedures (support system upgrades, change control, retrospective validation, software add-on installations where capable).
Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
Provide support during regulatory inspections and internal audits
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 and a minimum of 10 years of relevant Quality Assurance experience.
An advanced degree (MS) and a minimum of 5 years relevant experience will also be considered
Additionally, you have:
Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..
Experience with Veeva systems, LIMS (e.g., Labware), Chromatography Data Systems (e.g., Waters Empower, Nugenesis, Thermo Chromeleon), and/or Electronic Lab Notebooks (ELN) is required.

Preferred experience in Data Integrity, 21 CFR Part 11, Annex 11, GAMP 5, SDLC (Agile or Waterfall), CSA
Must have excellent communication skills (verbal and written).
Highly organized with a strong attention to details, clarity, accuracy, and conciseness.
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
$177,000.00-242,000.00 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.