Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Develop and execute QC strategy to support clinical product testing and commercial launch.
Lead and provide oversight of analytical method validation and lifecycle management.
Lead complex investigations and champion data integrity principles.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.
Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.
Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.
Provide technical and strategic leadership for late-stage CMC activities.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports.
Lead CMC meetings and ensure teams are aligned with overall CMC and program strategy.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.
Serve as primary project coordinator for Quality Risk Management processes and strategic continuous improvement initiatives.
Collaborate with cross-functional teams to ensure compliant execution of quality risk activities and analyze QMS trends for improvement opportunities.
Provide administrative support, assist in authoring SOPs, and function as a Super User for QRM technology as needed.
Vertex Pharmaceuticals is a biotechnology company focused on discovering, developing, and commercializing innovative medicines for serious diseases. It has a global workforce and a culture centered on scientific research and improving patient lives through therapeutic breakthroughs.