Senior QA Auditor - 60% - 80%

Do you want to use your strong analytical, problem-solving skills to help find treatments for rare disease patients? About Healx Healx is an AI-powered tech bio company that is redesigning drug discovery. With 10,000 rare diseases affecting 400 million people globally, 90% of which have no approved treatment, Healx is on a mission to pioneer the next generation of drug discovery to help rare disease patients in need. We combine data, artificial intelligence and deep pharmacology expertise to develop treatments more quickly and cheaply than traditional drug discovery. Diversity and inclusion sits at the heart of our mission to help people with rare diseases, and we believe that attracting and empowering a diverse team is critical to achieving this goal. We welcome applications from people from all backgrounds and walks of life. Below we have included the qualities that we feel are required for you to excel in this role; however we appreciate that people can apply transferable skills from all walks of life and experience. If you think you have what it takes, love our mission and resonate with our values but are worried you don't tick every box – we still want to hear from you and encourage you to apply! Our Values Care for Rare – Rare disease patients are at the heart of what we do Grow as individuals – We are learners always seeking to enhance our expertise Win as a team – We strive to remain inclusive and diverse and we celebrate successes and lessons together Innovate and deliver – Our mission requires rapid innovation and calculated risks that won’t compromise our high standards The role Healx is looking for a part-time (60% - 80%) experienced Senior QA Auditor to join the team to lead strong analytical, problem-solving activities that ensure all clinical research (GCP) and manufacturing (GMP) related activities performed by Healx personnel and vendors are carried out in accordance with industry expectations, SOPs, and international regulations. Healx’s Senior QA Auditor will be working closely with Healx’s Clinical team, they will ensure Healx is inspection-ready and drives continuous quality improvement across both clinical and manufacturing activities. They will ensure all clinical research activities at Healx complies with GCP standards, SOPs, and international regulations, execute Healx’s annual audit plan, and support the team with risk management planning and training. The GMP aspect of this role involves ensuring Healx’s investigational products meet strict GMP standards through Healx’s QMS management. Key duties include working with Healx’s CMC Director to manage review batch records, auditing (internal, external, supplier), deviation/CAPA investigation, conducting root cause analysis, documentation and change control, handling out-of-spec results, product release and ensuring adherence to regulations. You will partner closely and report to the Global Head of Clinical Development to provide the strategic oversight and tactical execution of the Quality Management System (QMS). You’ll be closely collaborating with CMC, Regulatory Affairs, Pre-Clinical and Clinical Operations personnel to maintain compliance and drive continuous improvement in Healx’s QMS and manufacturing of Healx’s investigational products.