Manager, Quality Control. Job in Bridgewater LilyLifestyle Jobs

Manager, Quality Control (QC) We are seeking a Manager, Quality Control (QC) to lead QC activities conducted at external contract laboratories for inhalation and small molecule drug substance and drug products. Reporting to the Associate Director, QC, you will independently manage analytical projects, deviations, investigations, and ensure compliance with cGMP, regulatory standards, and Insmed's quality expectations. What You'll Do Independently manage and provide technical oversight of QC testing conducted at contract laboratories for drug substances and drug products, with emphasis on inhalation dosage forms Lead analytical project activities from initiation through completion, ensuring testing aligns with project timelines, quality expectations, and regulatory requirements Review analytical data packages, protocols, test results, and reports for completeness, accuracy, and compliance with internal and external standards Independently manage deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and change controls, including performing root cause analysis and implementing effective CAPAs Support and drive analytical method implementation and troubleshooting related to APSD, MMAD, delivered dose, and particle size distribution testing Ensure timely review and approval of Certificates of Analysis (CoAs), method validation/transfer protocols, and analytical methods from external labs to enable batch disposition Lead the development and review of product specifications and justification documents for clinical and commercial programs Author, review, and contribute to QC sections of regulatory submissions (INDs, NDAs) and prepare responses to regulatory agency inquiries Monitor and evaluate contract laboratory performance metrics, providing technical guidance and escalating issues as needed Drive continuous improvement initiatives within QC and external lab oversight processes Who You Are You have a Bachelor's degree in Chemistry, Biochemistry, or a related scientific field and at least 4 years of Quality Control experience in the biotech/pharmaceutical industry. Experience in analytical testing of inhalation and/or small molecule drug products Strong understanding of cGMP regulations, ICH guidelines, and global compendial standards (USP/EP/JP) Experience with oversight of contract testing labs Experience reviewing analytical data and technical documents such as CoAs, protocols, and regulatory submissions Analytical and problem-solving skills, including participation in investigations and CAPA implementation Effective communication and collaboration skills with ability to interface with internal teams and external partners Time management and prioritization abilities, with attention to quality and compliance Nice to have (but not required) Advanced degree (MS) Familiarity with combination products Location This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence. Travel Requirements Occasional domestic travel approximately 10%. Pay Range $124,000.00 - $161,000.00 Annual Benefits Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP) Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back #J-18808-Ljbffr United Cerebral Palsy of Georgia