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 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. Overview Reporting to the Director of Quality, QC Oversight, the QA Manager, will provide critical Quality Assurance support for Quality Control operations supporting global development and commercial products. This individual will ensure that QC laboratory processes, systems, and data adhere to relevant regulatory standards, internal policies, and industry standards. The QA Manager will collaborate closely with QC teams, internal and external laboratories, and critical suppliers to drive operational perfection, regulatory compliance, and continuous improvement. Responsibilities Responsibilities (Essential Role Responsibilities): * Provide QA oversight to QC operations, ensuring compliance with GMPs, company policies and procedures, and regulatory standards and requirements for drug, medical devices, and combination products. * Handle quality relationships with laboratories and suppliers, ensuring consistent high-quality standards and active Quality engagement. * Partner with QC teams to address quality issues and drive productivity and compliance improvements. * Review, approve, and support QC documents including SOPs, deviations, CAPAs, investigations, change controls, equipment and raw material qualifications, and method validations. * Perform risk assessments for laboratory operations and support implementation of risk mitigation strategies. * Be responsible for the laboratory equipment program, including qualification, calibration, and maintenance (PM). * Support method transfers, method validations, stability programs, and trending of analytical data. * Support supplier and internal audits, as necessary. * Track and analyze laboratory metrics and trend analyses, proposing and leading improvement initiatives. * Perform other responsibilities as assigned. 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 QA experience (or advanced degree with 8+ years) within the pharmaceutical or biotechnology industries, preferably supporting QC laboratories. * Small molecule (e.g., tablets) product experience required; biologics and/or cell therapy experience is a plus. * Strong knowledge of cGMP's, regulatory requirements, and laboratory compliance standards (i.eg. FDA, EMA, ICH) applicable to drug, medical device, and combination product testing. * Experience supporting laboratory method validation, method transfer and equipment/ raw material qualification. * Knowledge of data integrity principles, risk management tools (e.g., FMEA), and laboratory compliance standard methodologies. * Direct experience with change controls, deviations, investigations, CAPAs, and root cause analysis. * Solid knowledge of QC laboratory operations (equipment qualification, methods, laboratory systems) * Excellent communication (verbal and written) * Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. * Strong problem-solving and critical thinking skills with the ability to make sound decisions independently. * Ability to handle multiple projects and work independently in a dynamic environment. * Experience with Quality and Laboratory Systems such as Veeva, Empower, BRAM, and LIMS. * Familiarity with laboratory techniques (e.g., HPLC/UPLC, LC-MS, pH, IR, Dissolution) preferred. * Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) Travel : * Up to 20% Domestic/International Travel Requirements * Hybrid role with up to 2-3 days in office per week. Salary Range $111,000 - $156,133 a year Compensation & Benefits 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. Additional Information 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 [email protected] 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.