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.

 

	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.

 

Reporting to the Director of Clinical Quality Systems, and with a dotted line to the AD of GLP and GCLP QA, the Manager of GLP & GCLP Quality Assurance (CQA) serves as a QA representative on the development team assuring quality and regulatory compliance related to GLP and other related activities performed by Insmed. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes align with applicable international and national standards, regulations, and guidelines. This is a remote position.

Responsibilities:

• Give to and support the maintenance of a risk-based and scientific-based quality system to support GLP.
• Assist with the development, design, and implementation of a strategic audit plan, ensuring that the activities are conducted and reported according to SOPs and regulations.
• Perform audits of contract research organizations, contract testing laboratories, and internal systems/processes.
• Support the evaluation and acceptability of service providers for potential use.
• Support cross functional working groups to identify and mitigate GLP quality and compliance issues.
• Champion compliance with US FDA 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies, OECD Principles of Good Laboratory Practice, MHLW (Japan), and the regulations of other countries that are signatories of the OECD Mutual Acceptance of Data Agreement.
• Handle quality documentation in Veeva QMS and Vault.
• Provide Quality support during regulatory agency inspections.

Qualifications:

• Minimum BS degree in Biology or Chemistry or related life sciences field required with minimum 3-5 years of experience.
• An understanding of regulations, development processes and regulatory inspection procedures is required. Experience working with regulators and internal staff to help prepare for inspections preferred.
• GLP audit experience is required including ability to conduct external audits of CROs and supporting laboratories with responsibility for writing audit reports and reviewing and tracking CAPAs.
• Must demonstrate practical working knowledge of GLP regulations.
• Broad knowledge of risk-based quality systems approaches.
• 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 15-20%.

$111,000 - $156,133 a year

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.

 

 

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.