Manager, Quality Assurance

Insmed Inc. • Bridgewater, NJ • 1d ago

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

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