Senior Manager - Development Quality Assurance

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 from leading workplace and culture organizations, including Science's Top Employers, Great Place To Work® in the U.S., and Fortune's Best Workplaces in BioPharma.

For patients, for each other, and for the future of science, we’re in. Are you?

About the Role:

Reporting to a Director of Clinical Quality Assurance, the Sr. Manager of Clinical Quality Assurance serves as a Development QA (DevQA) representative on the development team assuring quality and regulatory compliance related to GCPs and other related activities performed by Clinical Study (Trial) Teams. You will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines.

What You'll Do:

In this role, you’ll have the opportunity to Serve and maintain qualification as a GCP Subject Matter Expert (SME) as well as contribute to and support the maintenance of a risk-based and scientific-based quality system to support GCP.   You’ll also:

• Ensure that a strategic audit plan is implemented and activities are conducted and reported according to SOPs and regulations.
• Perform audits of investigator sites, TMFs, vendors, and internal systems/processes.
• Support the evaluation and acceptability of clinical vendors/suppliers.
• Support strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.
• Establish and foster compliance with ICH E6 Guideline for Good Clinical Practice.
• Provide support and coaching to other staff members to develop additional quality and auditing resources.
• Manage quality documentation in Veeva QMS.
• Act as company’s representative during regulatory agency inspections.

Who You Are:

Basic Qualifications 

You meet the following minimum education and experience requirements:  

• BA/BS degree in Biology or Chemistry or related life sciences discipline along with a minimum of 5 years of GCP experience.

Preferred Qualifications 

In addition to meeting the basic qualifications above, you will also possess some or all of the following:    

• An understanding and practical working knowledge of clinical regulations, good clinical practices, development processes, and regulatory inspection procedures.
• Experience in developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are consistent with current regulatory and GCP requirements.
• GCP audit experience with the ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs.
• Ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations with responsibility for writing audit reports and reviewing and tracking CAPAs.
• Experience in supporting regulatory agency inspections and working with regulators and internal staff to help prepare for inspections.
• Broad knowledge of risk-based quality systems and approaches consistent with ICH E6 for Good Clinical Practice.
• Solid experience with Phases I-IV (particularly Phase III); experience with Regulatory approval, NDAs and MAAs is preferred.
• Ability to foster a collaborative/partnership environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team. building while maintaining quality and compliance.
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.

Where You’ll Work 

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events may be expected.  

Travel Requirements

This position involves frequent domestic/international travel (up to 25-30%) to support clinical QA including external audits.

#LI-hybrid

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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.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected].