Manager, GLP Quality Assurance Position Available In Somerset, New Jersey

Job Description:

Company Description Insmed is a global biopharmaceutical companyon a mission to transform the lives of patients living with seriousand rare diseases. Our most valuable resource is our employees, andeverything we do is motivated by a patients-first mentality. We arededicated to growing our team with talented individuals from aroundthe world who are willing to challenge the status quo, solveproblems, and work collaboratively with a sense of urgency andcompassion. Guided by our core values of collaboration,accountability, passion, respect, and integrity, we aim to fosteran inclusive, diverse, and flexible work environment, where ouremployees are recognized for leaning in and rolling up theirsleeves. If you share our vision and want to work with the mostdedicated people in the biopharma industry, come to Insmed toaccelerate your career. Recognitions Consistently Ranked Science ‘sTop Employer Insmed is dedicated to creating a collaborativeenvironment where our team can thrive. Every day, our employeesturn their passion for science and research into innovativesolutions for patients. That’s why we’ve been named the No. 1company to work for in the biopharma industry in Science ‘s TopEmployers survey for four years in a row. A Certified Great Placeto Work® We believe our company is truly special, and our employeesagree. In July 2024, we became Great Place to Work-certified in theU.S. for the fourth year in a row. We are also honored to have beenlisted on the Best Workplaces in Biopharma™, Best Workplaces in NewYork™, PEOPLE® Companies That Care, Best Workplaces for Women™,Best Workplaces for Millennials™, and Best Medium Workplaces™lists. Overview Reporting to the Director of Clinical QualitySystems, and with a dotted line to the AD of GLP and GCLP QA, theManager of

GLP & GCLP

Quality Assurance (CQA) serves as a QArepresentative on the development team assuring quality andregulatory compliance related to GLP and other related activitiesperformed by Insmed. The incumbent will provide support and promotecollaboration internally and externally to ensure all systems,processes and their outcomes align with applicable internationaland national standards, regulations, and guidelines. This is aremote position.

Responsibilities Responsibilities:

Give to andsupport the maintenance of a risk-based and scientific-basedquality system to support GLP. Assist with the development, design,and implementation of a strategic audit plan, ensuring that theactivities are conducted and reported according to SOPs andregulations. Perform audits of contract research organizations,contract testing laboratories, and internal systems/processes.

Support the evaluation and acceptability of service providers forpotential use. Support cross functional working groups to identifyand mitigate GLP quality and compliance issues. Champion compliancewith

US FDA 21 CFR

Part 58 Good Laboratory Practice for NonclinicalLaboratory Studies, OECD Principles of Good Laboratory Practice,MHLW (Japan), and the regulations of other countries that aresignatories of the OECD Mutual Acceptance of Data Agreement. Handlequality documentation in Veeva QMS and Vault. Provide Qualitysupport during regulatory agency inspections.

Qualifications:

Minimum BS degree in Biology or Chemistry or related life sciencesfield required with minimum 3-5 years of experience. Anunderstanding of regulations, development processes and regulatoryinspection procedures is required. Experience working withregulators and internal staff to help prepare for inspectionspreferred. GLP audit experience is required including ability toconduct external audits of CROs and supporting laboratories withresponsibility for writing audit reports and reviewing and trackingCAPAs. Must demonstrate practical working knowledge of GLPregulations. Broad knowledge of risk-based quality systemsapproaches. Must be able to foster a collaborative/partnershipenvironment, adapt to other personalities in a respectful mannerthat is conducive to goal achievement and team building whilemaintaining quality and compliance. Highly organized with a strongattention to detail, clarity, accuracy, and conciseness. Mustexhibit Insmed’s five (5) core values of: Respect, Passion,Integrity, Collaboration and Accountability. Individuals mustdemonstrate the ability to interact successfully in a dynamic andculturally diverse workplace. Ability to travel both domestic andinternationally, approximately 15-20%. Salary Range $111,000 -$156,133 a year Compensation & Benefits At Insmed, we’re committedto investing in every team member’s total well-being, now and inthe future. Our benefit programs vary by country but we offer thefollowing to all Insmed team members, regardless of geographiclocation: Flexible approach to how we work Health benefits andtime-off plans Competitive compensation package, including bonusEquity 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 Opportunityemployer. We do not discriminate in hiring on the basis of physicalor mental disability, protected veteran status, or any othercharacteristic protected by federal, state, or local law. Allqualified applicants will receive consideration for employmentwithout regard to sex, gender identity, sexual orientation, race,color, religion, national origin, disability, protected Veteranstatus, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded toInsmed. Insmed will not be responsible for any fees arising fromthe use of resumes through this source. Insmed will only pay a feeto agencies if a formal agreement between Insmed and the agency hasbeen established. The Human Resources department is responsible forall recruitment activities; please contact us directly to beconsidered for a formal agreement. Insmed is committed to providingaccess, equal opportunity, and reasonable accommodation forindividuals with disabilities in employment, its services,programs, and activities. To request reasonable accommodation toparticipate in the job application or interview process, pleasecontact us by email at TotalRewards@insmed.com and let us know thenature of your request and your contact information. Requests foraccommodation will be considered on a case-by-case basis. Pleasenote that only inquiries concerning a request for reasonableaccommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date postedor until the position is filled.