Sr. Quality Engineer, Digital System QA

Insmed Inc. • Bridgewater, NJ • 1w 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 This position is primarily responsible for supporting and providing oversight to Validation and Life Cycle Management activities for GxP Computer Systems used to support GxP business areas such as supply chain, manufacturing, quality control, warehouse, and clinical operations as Quality Assurance representative. This also includes GxP Computer Systems supporting Quality Systems such as Electronic Document Management System (EDMS), Quality Management System (QMS), Learning (Training) Management System (LMS) and Labeling Management Platform. The position requires to have knowledge and understanding of key Quality Systems Process such as Change Control, Deviation, CAPA, Supplier Quality, Internal/External Audit, Quality Complaints and Production Process Control to support GxP computer system utilized in these areas and provide guidance to business users conducting quality system activities as QA. Responsibilities Responsibilities will include, but not necessarily be limited to, the following: Guide Business Owners and IT System Owners for computer systems validation and lifecycle management deliverables as Digital Systems QA in accordance with applicable regulations, guidelines, policies and procedures. Facilitate Computer System Life Cycle Management activities such as IT Change Control, System Releases/Upgrades, Periodic Reviews, Audit Trail Review, User Access Review, Incidents as Digital System QA. Train, assist and advise business users on executing GxP computer system validation life cycle management activities within EDMS/QMS. Lead GxP IT Change Control cross functional forum assessing GxP Computer System changes to be implemented for continuous improvement. Authors SOPs and Quality System records such as Document Change Control, Change Control, Deviation, CAPA, Audit Observations, Risk Assessments, Periodic Review, and assists other departments with the generation, review, approval and maintenance of such records. Provide support during regulatory inspections, internal audits and supplier qualifications. Experience with Veeva systems is preferred. Experience implementing, validating, and controlling GxP Computer Systems in validated state in an FDA or equivalent regulated settings. * Role-related knowledge: Working knowledge of all GxP regulatio

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