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 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 Director of Digital Systems Quality Assurance (DSQA) is responsible for establishing, leading, and continuously improving the quality oversight of GxP digital systems supporting gene therapy manufacturing, pharmaceutical development, and analytical laboratories. This role ensures that computerized systems, data integrity controls, and digital workflows meet global regulatory requirements, internal quality standards, and lifecycle management expectations. This position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global and site GxP systems for Gene Therapy manufacturing, quality control, warehouse, including the NJ Research Development Location as necessary. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents.

What You'll Do:

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.

You'll also:

• 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.
• Ensure deployed solutions are in alignment with business needs, in compliance with Data Integrity requirements

• 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).
• Work with project teams and business/quality representatives to ensure compliance with regulatory requirements such as FDA, EMEA, PMDA, CAPAs, GxP, etc
• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.
• 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 support during regulatory inspections and internal audits
• Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.
• 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
• Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.

Who You Are:

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..
• 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).
• Demonstrate ability to manage projects and variable workloads.
• Highly organized with a strong attention to details, clarity, accuracy, and conciseness.
• Must successfully exhibit Insmed's five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

Travel

• Domestic and/or International travel may be required 30%

Where You'll Work

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

Relocation is available for the right candidate

#LI-SK1
#LI-SK - Hybrid

Pay Range:
$177,000.00-242,000.00 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 [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.

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 [email protected]; and/or
• An alternative selection process by emailing [email protected].
• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at [email protected].