Senior Manager, Quality Assurance Business Process System Owner

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:

You will serve as the Quality Business Process & System Owner (BPSO) for global GxP platforms including Veeva QMS, Veeva QualityDocs, DocuSign, Veeva LMS, and Veeva Labeling. You will be accountable for business requirements, governance, compliant use, lifecycle priorities, adoption, and continuous improvement. In partnership with Business Process Owners (BPO), IT System Owners (ITSO), Computer System Validation (CSV), Digital Systems Quality Assurance (DSQA), and process owners, the BPSO defines WHAT and WHY while ITSO owns the technical HOW. You will lead the business/Quality perspective for projects, releases, changes, access governance, incidents, validation testing, performance monitoring, and inspection readiness.

What You'll Do:

In this role, you'll have the opportunity to serve as designated BPSO for Veeva QMS, Veeva QualityDocs, DocuSign, Veeva LMS, and Veeva Labeling, accountable for business governance, fit-for-purpose use, lifecycle priorities, and continuous improvement. You'll also:

• Define and prioritize business needs, system capabilities, roadmap objectives, and user/functional requirements in partnership with ITSO, CSV, DSQA, process owners, and other stakeholders.
• Lead business-owner activities for patches, releases, upgrades, and system changes, including business impact assessment, change control review/approval, readiness, stakeholder communication, and business validation testing.
• Maintain clear role boundaries and segregation of duties: BPSO defines and approves business needs and impact; ITSO owns technical design, configuration, provisioning, implementation, and technical issue resolution; CSV and DSQA provide validation and independent compliance oversight.
• Own business access governance, including role design, business need and competency/training requirements, access approvals, and periodic access reviews; partner with ITSO for provisioning and system administration.
• Provide business leadership for production issues and incidents, including business/process impact assessment, stakeholder communication, deviation initiation/support when validated state or data integrity may be impacted, and business-owner closure approval.
• Lead BPSO activities for new implementations and major enhancements, including business need definition, GxP risk assessment, requirements, data integrity/functional risk assessments, PQ/UAT, business SOPs/work instructions, business continuity planning, and adoption.
• Drive standardization and optimization of Quality processes enabled by the platforms; chair cross-functional governance/SME forums, manage demand and priorities, escalate risks and dependencies, and leverage new capabilities to reduce manual effort while maintaining compliance.
• Define and monitor system/process performance metrics and trends; maintain business-facing documentation and training requirements; and support regulatory inspections, audits, supplier activities, and ongoing inspection readiness.

Who You Are:

You have a minimum of a Bachelor's degree in in Computer Science, Management Information Systems (MIS), Engineering, Science, Quality, or a related field required as well as a minimum of 7 years of experience of relevant experience in the pharmaceutical, biotechnology, or other GxP-regulated industry, including demonstrated experience with computerized quality systems and business/process or system ownership.

You are or also have:

• Demonstrated experience leading cross-functional GxP system lifecycle activities, including requirements, changes/releases, validation testing, incidents, access governance, and continuous improvement.
• Experience with Veeva Vault Quality applications, particularly Veeva QMS and Veeva QualityDocs, is strongly preferred; experience with learning management, electronic signature, and labeling platforms is preferred.
• Working knowledge of GxP Quality Management System processes and the ability to translate business process needs into scalable, compliant system requirements and operating models.
• Role-related knowledge: Must have knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, computerized system lifecycle management, and SDLC methodologies.
• Strong business analysis, requirements definition, process mapping, risk assessment, testing/UAT, change-management, and project leadership capabilities.
• Demonstrated ability to lead complex cross-functional initiatives, manage competing priorities, influence without direct authority, and make clear risk-based decisions in a global environment.
• Strong analytical and communication skills, including the ability to define meaningful metrics, identify trends, communicate with technical and non-technical stakeholders, and present effectively to senior leaders.
• Highly organized with strong attention to detail, 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.

Where You'll Work

This is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work 2 days of the week remotely, with in-person collaboration when it matters most.

#LI-hybrid

#LI-EG1

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. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

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.