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Associate Director, Clinical Quality Assurance
3 months ago
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
Named Science's Top Employer in 2021, 2022, and 2023
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 were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three 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 Associate Director of Clinical Quality Assurance (CQA) serves as a CQA lead representative on the development team assuring quality and regulatory compliance related to GCPs and other related activities performed by Medical/Clinical Departments. The incumbent 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.
Responsibilities Responsibilities (Essential Role Responsibilities):
GCP Subject Matter Expert (SME).Contribute to and support the maintenance of a risk-based and scientific-based quality system to support GCP.Ensure that a strategic audit plan is developed, designed, and implemented. That the activities are conducted and reported according to SOPs and regulations.Perform audits of investigator sites, vendors, and internal systems/processes.Support the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality and Compliance.Support strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.Establishing 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 and Vault.Act as company's representative during regulatory agency inspections.Position Requirements (Required and/or Preferred Skills, Experience and Education):Minimum BS degree in Biology or Chemistry or related life sciences discipline required with minimum 7-10 years of experience.Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered. Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required.An understanding of regulations, development processes and regulatory inspection procedures is required.Experience developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential.GCP audit experience is required including 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.Must demonstrate practical working knowledge of GCP regulations.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.Requires solid experience with Phases I-IV (particularly Phase III); experience with Regulatory approval, NDAs and MAAs is preferred.Must be able 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.Must exhibit Insmed's five (5) core values of: Respect, Passion, Integrity, Collaboration and Accountability.Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.Ability to travel both domestic and internationally, approximately 25%-30%#LI-JT1#LI-RemoteTravel Requirements
Ability to travel both domestic and internationally, approximately 25%-30%
#LI-Remote
Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $139,000.00 to $195,200.00 per year
Compensation & Benefits
We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
Flexible approach to where and how we work, regionally basedCompetitive compensation package including bonus Stock options and RSU awardsEmployee Stock Purchase Plan (ESPP)Flexible Vacation Policy Generous paid holiday schedule and winter breakADDITIONAL U.S. BENEFITS:
401(k) plan with company matchMedical, dental, and vision plansCompany-provided Life and Accidental Death & Dismemberment (AD&D) insuranceCompany-provided short and long-term disability benefitsUnique offerings of pet, legal, and supplemental life insuranceFlexible spending accounts for medical and dependent careAccident and Hospital Indemnity insuranceEmployee Assistance Program (EAP)Mental Health on-line digital resourceWell-being reimbursementPaid leave benefits for new parentsPaid time off to volunteerOn-site, no-cost fitness center at our U.S. headquartersAdditional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. 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.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
