Senior QA Auditor - 60% - 80%

Job description

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. ### Key responsibilities **GMP Key Responsibilities** - 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 **Quality Assurance & Quality System Management responsibilities**: - Develop, write and maintain company SOPs in accordance with industry expectations, ICH-GCP and GMP guidelines and regulations where Healx operates - Maintain and improve Healx’s Quality Management System (QMS), including delivery of training and tracking of training across company, change control (including regulatory impact assessment in coordination with Regulatory Affairs), deviations, CAPAs, and risk assessments, in cooperation with the management team (MT), department directors and with support from the Clinical Team - Prepare and execute the annual audit plan (scope to include compliance with QMS, external audits at investigational sites and third-party vendors) and in ensuring vendors maintain their qualification - Ensure Healx is inspection ready at all times and conduct self-inspections and advise the Management Team and department directors on vendor selection and evaluation process - Liaise with Regulatory Affairs as the primary point of contact for official Health Authority inspections (e.g., MHRA, FDA, EMA), ensuring coordinated communication and timely submission of responses to inspection findings - Manage and oversee third party auditors to ensure compliance with Healx’s audit standards and current guidelines - Assist in the preparation, management, hosting and follow-up of audits/inspections by third parties - Provide recommendations for corrective and preventive actions (CAPAs) resulting from audits and provide advice on the resolution of any other quality-related issues, escalations **Risk Management:** - Assist the Clinical team in preparing a project-specific Risk Management Plan. - Assist the Clinical team in preparing risk-based monitoring plans - Train personnel on Risk Management as appropriate ### You will know you are successful when - Have successfully managed the interface between Quality and Regulatory Affairs, specifically regarding the regulatory impact of manufacturing changes and clinical trial amendments - Have ensured that audit results are monitored for trends and advise the Leadership Team, and staff, on improvements - Sucessfully assisted the Leadership Team in preparing and maintaining a corporate Risk Management Plan (RMP) - Have translated guidelines, rules and regulations into clear and usable recommendations / procedures ### What we're looking for You have at least 7 years experience in pharma, biotech and/or CRO industries, preferably in both Clinical Research Operations and Quality Assurance, and you’re now looking for your next step up. You are excited about taking on new challenges and responsibilities in a mission-driven startup. We'd love to hear from you if your experience and interest overlaps with this profile: - Bachelor’s degree in Science, Life Science or Health related field, or in Quality Management - Deep understanding of **ICH-GCP** and **GMP** guidelines, working knowledge of applicable EU directives/regulations, UK legislation and international clinical trial regulations (e.g., EU GMP, US FDA cGMP) - Strong analytical, problem-solving, and decision-making abilities - Process oriented and pragmatic - Excellent communication and interpersonal skills for leading teams and stakeholders - Willingness to travel to the US (once or twice a year) - Hands-on and collaborative approach to strong analytical, problem-solving - Interest in biotech/ techbio and its impact of improving patient outcomes ***It’s a bonus if you have:*** - Experience with electronic Quality Management Systems (eQMS) - Ability to work in cleanroom environments and experience of conducting GMP audits