Director, Clinical Quality Assurance

Company: Insmed Incorporated
Location: Bridgewater
Posted on: July 4, 2025

Job Description:

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row. A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview Reporting to the Sr. 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 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. Responsibilities Responsibilities (Essential Role Responsibilities): 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.) Position Requirements (Required and/or Preferred Skills, Experience and Education): 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 effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required. Experience with combination products a plus. 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.LI-JT1LI-Remote Salary Range $171,000 - $239,667 a year Compensation & Benefits At Insmed, we're committed to investing in every team member's total well-being, now and in the future. Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location: Flexible approach to how we work Health benefits and time-off plans Competitive compensation package, including bonus Equity Awards (Long-Term Incentives) Employee Stock Purchase Plan (ESPP) For more information on U.S. benefits click here. Additional Information 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.

Keywords: Insmed Incorporated, Scranton , Director, Clinical Quality Assurance, Science, Research & Development , Bridgewater, Pennsylvania