Compliance Manager, Clinical Supply Chain

Compensation

$124,000.00 - $124,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Job 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:

We're looking for a Compliance Manager, Clinical Supply Chain on the Clinical Supply Chain team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Clinical Supply Chain, you'll be responsible for managing compliance activities throughout the supply chain for assigned studies and projects ranging from phase I to phase IV clinical studies.

What You'll Do:

In this role, you'll have the opportunity to ensure audit readiness for potential inspections to support the Clinical Supply Chain and Technical Operations and serve as main point of contact for compliance within the clinical supply on designated studies and projects function. You'll also:

Assist in developing the TMF index to better support the supply chain for assigned studies and/or programs

Support IRT system design and UAT requirements for assigned studies. Perform UAT testing on IRT systems

Support Change Control management activities within the clinical supply chain

Coordinate with and manage external packaging, labeling and distribution vendors

Represent Supply Chain & Logistics at cross-functional study level meetings to ensure timely updates and information to assigned studies/projects

Communicate relevant project information to internal and external stakeholders

Develop and present slide decks, coordinate drafting of reports, and edit documents for preparation of business development activities

Identify, report, manage and mitigate risks in the clinical supply chain

Provide regular updates to the TMF as per regulatory requirements

Understand anernal stakeholders to ensure supply compliance at each node within the supply chain

Coordinate with Supplier Relationship Management for clinical suppliers, including maintaining key performance metrics

Coordinate with Insmed contracted clinical supply organizations to appropriately disposition clinical supply material

Draft SOPs, WPs and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements

Work closely with supply chain colleagues to ensure consistency across processes and tools and implementation improvements to show sustainable results

Responsible for managing the groups training curriculum

Who You Are:

You have a bachelor's degree along with 5+ years of experience in drug development, clinical supply chain management and/or clinical manufacturing operations.

You are or you also have:

Ability to identify risks

in process management and develop a solution-based approach that is operationally achievable

Proficient with Microsoft Applications (Excel, PowerPoint, Word)

Experience working with and/or managing external vendors

Working knowledge of GMP, GCP and ICH guidelines

Strong teamwork and collaboration skills

Strong ability to handle multiple projects simultaneously

Act with a sense of urgency

Nice to have (but not required):

MS Project and other computer software demand & supply related systems are a plus

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 when it matters most.

Travel Requirements

This role requires occasional global travel (approximately 5%-15%)

#LI-BA

LI-HYBRID

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 [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.

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjM4ODY3LjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t

Place of Work

On-site

Requisition ID

R3761-3486