Senior Quality Specialist (Document Control and Record Management)

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:

Reporting to the Associate Director, Quality Systems, Document Control, the Senior Quality Specialist, Quality Systems will play a key role in supporting QA and Regulatory Compliance activities for Insmed. You will support the Global Document Control and Records Management programs within the Quality Management System (QMS) at Insmed, ensuring documentation and systems supporting GxP operations meet global regulatory requirements, internal quality standards, and lifecycle management expectations.

In coordination with the Associate Director, Quality Systems, Document Control, primary areas of responsibility include monitoring, reviewing, and approving Quality Documents in the electronic QMS, managing and administering the Document Control System, supporting the New Jersey Site Physical Record Archive Room, generating Quality System Metrics, and owning and authoring related SOPs for these systems. Partnering with Quality Assurance, Regulatory Affairs, Manufacturing, Technical Operations, and other cross-functional stakeholders, you will ensure documentation practices enable compliant operations and consistent quality standards.

What You'll Do:

In this role, you'll have the opportunity to support processes within the QMS Document Control and Records Management System including process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS process. You'll also:

• Maintains all activities to support Document Change Control process, including supporting controlled document life cycle, document change requests, classification, and periodic review.

• Support Global Records Management Program and supports on-site GxP Archive Room which includes archiving and storing of records, coordinating off-site storage, managing periodic record reconciliation, and assessing document retention against Global requirements.

• Review all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods and specifications, and technical documents, as applicable, ensuring all documents are maintained to latest revisions and format.

• Track all Document Change Controls for completeness, timely reviews, approvals, and closure.

• Ensure Data Integrity requirements as it pertains to Electronic/Digital Signatures and Document and Records Management are upheld.

• Report and trend on all open Quality Documents.

• Handle compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Presentation and communication of trending reports in respective Quality forums.

• Train QA and stakeholders in QMS processes.

• Review and update SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements. Participate in meetings to support colleagues in Global time zones (EMEA, APAC, California).

Who You Are:

You have a minimum of a BS degree in Chemistry, Life Science or related discipline preferred along with 3+ years of relevant Quality Assurance experience within pharma/biotech industry.

You are or you have:

• Direct experience with Document Control management in pharmaceutical or medical device products.

• Full understanding of cGMPs for pharmaceutical products. Familiarity with other GxPs (GCP, GVP, GDP, GLP).

• Experience with Health Authority inspections and/or internal audits preferred.

• Familiarity of pharmaceutical product manufacturing processes, medical devices, and analytical laboratory practices.

• Experience working with an electronic document management system (EDMS).

• Working knowledge of the Change Management System and understanding of thorough business impact assessments.

• Understand CSV process and deliverables. Prior experience writing and executing UAT/PQ scripts, risk assessments, and performing audit trail reviews preferred.

• Experience at reviewing procedural documents.

• Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for pharmaceuticals and/or ISO 14971.

• Understanding of risk-based decisions consistent with ICH Q9 principles.

Where You'll Work

This is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work remotely most of the time, with in-person collaboration 1 -2 days a week or upon manager's discretion.

Travel Requirements

This role requires occasional travel (approximately 10%).

#hybrid

#LI-EG1

Pay Range:

$100,000.00-126,500.00 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 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.