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.
Develop a deep understanding of customer workflows.
Champion Qualio's agentic compliance solutions.
Become an in-house expert on Qualio's product.
Qualio is an agentic quality and compliance management platform that helps regulated organizations get products to market faster with reduced risk. The Qualio team is an all-remote, globally distributed workforce with teammates in over ten countries.
Design and own the QA program, including frameworks for sampling and audit cadence.
Build structured feedback loops to identify systemic quality issues and remediation opportunities.
Translate QA signals into data-backed narratives to influence prioritization across teams.
Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest. Affirm is a remote-first company that offers competitive benefits and focuses on providing a simple and transparent pay structure.
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.
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.
Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development.
Lead human factor engineering activities as per the regulatory guidelines.
Manage project and program budgets and timelines effectively.
Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind. They seem to have a collaborative culture.
Develop, mentor, manage and coach SSU personnel to ensure quality standards.
Ensure SSU personnel work to the highest quality standards and maintain compliance.
Participate in the interview process for new SSU personnel by conducting CV review.
Precision for Medicine is a Clinical Research Organization with an integrated offering enabling the science of precision medicine. They combine clinical trial designs, operational and medical experts, biomarker and data analytics solutions, with a passion for rare diseases and oncology.
Drive quality for assigned suppliers, including quality plan implementation.
Own supplier results and drive improvements utilizing supplier scorecards.
Own supplier audits, ensuring compliance, and driving improvement plans where needed.
GE Vernova is committed to electrifying the world and decarbonizing it at the same time. They retain their legacy of quality and ingenuity while innovating for a new era of lower carbon energy.