Senior QA Auditor

Do you want to use your strong analytical, problem-solving skills to help find treatments for rare disease patients?

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!

• 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

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.

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.

• Review and co-approve Quality Technical Agreements with GMP vendors, and ensure any project study changes in scope are appropriately reflected

• Manage GMP documents, review and co-approve batch records, and ensure proper control and archiving of quality-related data

• Work closely with Regulatory Affairs to ensure that all manufacturing and clinical activities remain in strict alignment with current regulatory filings (e.g., IND, CTA, or MAA) and to support the preparation of regulatory submissions

• Product Release:
  Approve or reject raw materials, intermediates, and finished products, often involving data review and certification. Verify that batch documentation and product specifications comply with the 'Approved' versions filed with Health Authorities before final certification or release

• Investigations:
  Investigate out-of-specification (OOS) results, deviations, and trends, performing root cause analysis (RCA)

• Include-Represent QA as needed for any product complaints and on the SPEC Committee

• Work closely with 3rd party Production, R&D, QC, and Supply Chain teams and Regulatory Affairs teams to ensure chemistry, manufacturing, and control (CMC) compliance

• Develop, write and maintain company SOPs in accordance with…