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:
Reporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical Operations and Medical Departments. This role provides support and promotes collaboration internally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.

What You'll Do:

• Establish and maintain a risk-based and scientific-based quality system to support GCP.
• Oversee regulatory agency inspections and vendor audits.
• Ability to ensure that a strategic audit plan is developed, designed and implemented, and that the activities are conducted, and reports written according to SOPs and regulations.
• Oversee GCP activities (including internal or external audit observations and development of adverse trends) to ensure patient safety and data integrity.
• Supports strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.
• Supports the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality Assurance.
• Full understanding of and practical experience establishing and fostering 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. (SOPs, CAPAs, Deviations, etc.)

Who You Are:

• Minimum BS degree in Chemistry or related life sciences discipline required with minimum 8-12 years of experience.
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered.
• Requires solid experience supporting Phases I-IV (particularly Phase III); experience with Regulatory submissions and/or approval. Experience with gene therapy products is preferred.
• Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential.
• Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.
• Must be able to foster a collaborative environment, adapt to other personalities in a respectful manner that is conducive to goal achievement and team building.
• Must be able to prioritize work effectively to meet timelines.
• Excellent written/oral communications skills and presentation skills.
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Demonstrated ability to work independently, flexibility and the ability to manage variable workloads.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Travel:

Up to 15% flexible self-directed travel, both domestic and/or international.

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Pay Range:
$171,000.00-239,667.00 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.