Manager, 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 Quality, QC Oversight,the QA Manager, will provide critical Quality Assurance support forQuality Control operations supporting global development andcommercial products. This individual will ensure that QC laboratoryprocesses, systems, and data adhere to relevant regulatorystandards, internal policies, and industry standards. The QAManager will collaborate closely with QC teams, internal andexternal laboratories, and critical suppliers to drive operationalperfection, regulatory compliance, and continuous improvement.

Responsibilities Responsibilities (Essential RoleResponsibilities): Provide QA oversight to QC operations, ensuringcompliance with GMPs, company policies and procedures, andregulatory standards and requirements for drug, medical devices,and combination products. Handle quality relationships withlaboratories and suppliers, ensuring consistent high-qualitystandards and active Quality engagement. Partner with QC teams toaddress quality issues and drive productivity and complianceimprovements. Review, approve, and support QC documents includingSOPs, deviations, CAPAs, investigations, change controls, equipmentand raw material qualifications, and method validations. Performrisk assessments for laboratory operations and supportimplementation of risk mitigation strategies. Be responsible forthe laboratory equipment program, including qualification,calibration, and maintenance (PM). Support method transfers, methodvalidations, stability programs, and trending of analytical data.

Support supplier and internal audits, as necessary. Track andanalyze laboratory metrics and trend analyses, proposing andleading improvement initiatives. Perform other responsibilities asassigned. Position Requirements (Required and/or Preferred Skills,Experience and Education): BS degree in Chemistry, Engineering,Life Sciences, or related field with 10 years of relevant QAexperience (or advanced degree with 8 years) within thepharmaceutical or biotechnology industries, preferably supportingQC laboratories. Small molecule (e.g., tablets) product experiencerequired; biologics and/or cell therapy experience is a plus.

Strong knowledge of cGMP’s, regulatory requirements, and laboratorycompliance standards (i.eg.

FDA, EMA, ICH

) applicable to drug,medical device, and combination product testing. Experiencesupporting laboratory method validation, method transfer andequipment/ raw material qualification. Knowledge of data integrityprinciples, risk management tools (e.g., FMEA), and laboratorycompliance standard methodologies. Direct experience with changecontrols, deviations, investigations, CAPAs, and root causeanalysis. Solid knowledge of QC laboratory operations (equipmentqualification, methods, laboratory systems) Excellent communication(verbal and written) Highly organized with a strong attention todetail, clarity, accuracy, and conciseness. Strong problem-solvingand critical thinking skills with the ability to make sounddecisions independently. Ability to handle multiple projects andwork independently in a dynamic environment. Experience withQuality and Laboratory Systems such as Veeva, Empower, BRAM, andLIMS. Familiarity with laboratory techniques (e.g., HPLC/UPLC,LC-MS, pH, IR, Dissolution) preferred. Proficient in MicrosoftOffice (Word, Excel, PowerPoint, Outlook)

Travel :

Up to 20%Domestic/International Travel Requirements Hybrid role with up to2-3 days in office per week. Salary Range $111,000 – $156,133 ayear Compensation & Benefits At Insmed, we’re committed toinvesting in every team member’s total well-being, now and in thefuture. 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.