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 four 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:
• Engage on GxP Projects as a key team member.
• Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements.
• Ensure compliance and operational efficiency of validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.
• Onsite at San Diego site.

What You'll Do:

Responsibilities will include, but not necessarily limited to the following:

• Provide strategic leadership and decision making on CSV strategy

• Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions

• Coordinate all validation activities with outsourced validation vendor when managing cloud applications.

• Manage and provide oversight on multiple projects simultaneously.

• Coordinate and lead validation activities with internal stakeholders and project team members.

• Author CSV Documents (Validation Plans and Summary Reports)

• Assist/co-author requirements, testing, specification, and other validation project deliverables

• Ensure training requirements are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.)

• Provide real-time oversight and support during test execution

• Review executed protocols and provide test protocol deviation assessment and resolution guidance.

• Train, coach, and mentor GxP system owners.

• Provide CSV program trainings, lunch and learns and guidance to new stakeholders as well as refresher trainings for existing stakeholders and project teams.

• Provide operational support in maintaining systems in a validated state including Change Control Assessments, Upgrade and Patch assessments, Release assessments.

• Manage day-to-day operations of the CSV function including managing CSV system folders in the CSV SharePoint site, managing CSV documents in Veeva, routing documents for review and approval in Veeva etc.

• This role will participate in on site Change Control CAB meetings as the CSV lead.

Who You Are:

Position Requirements (Required and/or Preferred Skills, Experience and Education):

• 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems.
• 2+ years' in a managerial role with people/project oversight.
• 5+ years' experience developing and managing projects budgets and forecasts.
• Experience leading cross-functional teams
• Experience supporting audits or regulatory inspections.
• Experience with Veeva QualityDocs /QMS and understanding of document management principles.
• Solid working knowledge of CSV guidelines and FDA/EU regulations:
• • 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity.
• Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.
• Strong technical writing skills for authoring, reviewing and approving validation plans, requirements, testing documents and summary reports.
• Familiarity with cloud-based systems and SaaS validation
• Experience managing oversight of multiple enterprise projects and processes at one time.
• Experience in evaluating and validating AI solutions in regulated uses is preferred.
• Strong customer service skills for internal and external customers.
• Ability to multi-task and prioritize efforts effectively.
• Bachelor's or Master's in Computer Science, Engineering, Life Sciences, or a related field.

#LI-JTI

#LI-Onsite

Pay Range:
$119,000.00-167,267.00 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.

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 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.