Insmed | Senior Quality Engineer, Quality Assurance | bridgewater, nj

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 Biopharmaâ„¢, Best Workplaces in New Yorkâ„¢, PEOPLE® Companies That Care, Best Workplaces for Womenâ„¢, Best Workplaces for Millennialsâ„¢, and Best Medium Workplacesâ„¢ lists. Overview Reporting to the Associate Director of Quality Management Systems, the Sr. Quality Engineer will play a key role in managing QA and Regulatory Compliance activities for Insmed. This role directly influences Insmed GMP compliance through QA oversight, monitoring and review of Quality System activities. Primary areas of responsibility include, Monitoring, Review and Approval of Change Controls, facilitating Change Control Committee meetings, Monthly/Annual Quality System Metrics/Reports, and related SOPs for these systems. Additional responsibilities include training, trending, monitoring, QA review and approval of Quality Documents in the electronic Document Control System, and business continuity across other processes within the QMS team. Responsibilities * Primary responsibilities include overseeing processes within the QMS related to Change Control and electronic Document Control. This includes process design, monitoring for compliance, continuous improvement activities, metrics, and day-to-day operations for the specified QMS processes. * Maintains all activities to support Change Control processes. * Supports facilitation of Change Control Committee materials and prior review of Change Plans presented to the committee. * Facilitates feedback from Change Control Committee Members. * Coaches and guides process owners to ensure effective change control initiation, approvals, implementation and closure per applicable procedures and regulations. Collaboratively works with cross-functional departments to support change control activities. * Performs QA review of Change Controls. Ensures completeness and accuracy of content and compliance to all applicable SOPs and cGMP regulations. * Handles compilation of quality metrics for monthly trending, management review meetings and follow up for the closure of process improvements. Responsible for presentation and communication of trending reports in respective Quality forums. * Performs Quality review of documents to support Document Control processes. * Training of QA and stakeholders in QMS processes. Develops supplemental training materials. * Reviews and updates SOPs, policies, and standards regularly to ensure compliance with GxP standards, FDA/EMA/ICH and other applicable competent authority regulations and requirements. * Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems. * Assists in inspection readiness activities and plays a key role during inspections/audits. * Provides support during internal review, Audits, FDA Audits and Third-party consultant Audits. * Tracking and identifying trends of quality events, including but not limited to change controls. * Role will be cross trained on all QMS process for business continuity (Document Control, Deviation, CAPA, EC, etc) and will act as QA approver/reviewer as required.Qualifications: * * BS degree in Chemistry, Life Science or related discipline required, plus a minimum of 5 years of relevant To view the full job description, click here>

Created: 2024-12-11