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 Responsible for directing all quality related activities and process for a pipeline product in clinical phase studies. This includes but not limited to supplier relationships/auditing, batch review/release, site transfers, and internal document set up/review, QMS, weekly team meetings, packaging and labeling. In addition, responsible for facilitating transition from drug development to commercial product. Responsibilities * Experience in leading investigations, CAPAs, deviations and quality events to resolution and closure * Establish and maintain a risk-based and scientific-based quality system and decision making * Audit the manufacturing facilities of vendors, customers and outside contract organizations. * Approximately 15% Domestic and International travel * Responsible for facilitating and approving Quality Technical Agreements with vendors * Through a quality system approach, ensure phase appropriate GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence * Ability to apply phase appropriate GMP compliance principles to quality decisions * Ability to lead investigations, CAPAs, deviations and quality events to resolution and closure * Ability to transition phase 3 clinical stage material to commercial success * Manage the quality aspects of a large scope phase 3 clinical project from raw materials to manufacturing to packaging, distribution and release * Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate * Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials * Prepare, review and approve external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance function. Provide support and training to other staff members to develop additional auditing resources. * Act as company's representative during regulatory agencies and customer inspections * Identify and lead operational excellence initiatives, both in the department and company-wide, which result in the overall improvement in both areas * Partner with colleagues in other departments to increase the overall effectiveness of the Quality departmentQualifications: * Minimum BS degree in Chemistry, Life Science or related discipline plus 10 years. OR Masters, PHD, MBA and 7 years of experience preferred * Full understanding of cGMPs, GLPs and a working knowledge of GCPs. * Experience in effectively managing FDA inspections, working with regulators, and customer audits . * Understanding of device regulations and development processes. Understanding of FDA inspection procedures. * Familiarity of pharmaceutical product manufacturing processes. * Experience with Phase I thru IV, particularly Phase III; experience with Regulatory approval, NDAs aTo view the full job description, click here