Senior QA Auditor - 60% - 80%

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.

Healx works from a modern accessible office in the centre of Cambridge within easy reach of the train station. We offer a flexible, diverse and inclusive working environment that considers your individual needs and believes in maintaining a sustainable work-life balance and we are open to discussing flexible working arrangements. You will be welcomed by a team of colleagues with decades of accumulated experience in their areas of expertise, happy to help you develop your own skills in a highly collaborative environment and who are keen to provide guidance and support in your personal and career development plans.

Healx is a distributed team, and operates a hybrid working model. We recognise the benefits of home working for productivity, flexibility and focused virtual collaborations across distributed teams, while also valuing the importance of in-person interaction for building relationships and solving complex problems. Healx holds three all-company Team Days events each year at our Cambridge office and expects teams to come together in person for regular Team Workshops throughout the year.

Healx will provide you with support and guidance to help you do your best work and make an impact. We offer flexible working and believe in maintaining a sustainable work-life balance. 

• Financial - Competitive salary, share options, 7% employer pension contributions, life insurance of 4x base salary

• Health and Wellbeing - Private medical insurance, 25 days annual leave (plus bank holidays) with the option to purchase additional days to support a healthy work-life balance, wellbeing support via Spill and our Employee Assistance Programme

• Hybrid Working - Flexible and remote working options, home office set-up allowance, periodic in-person team days for company-wide collaboration and celebration

• Family Friendly - Enhanced family leave policies, miscarriage and fertility leave, flexible working practices

• Personal Development and Growth - Personal learning and development budgets, regular personal development conversations and career support

• Community Engagement and Support - One paid day off per year to volunteer for a cause aligned with our mission of supporting patients living with rare diseases; the opportunity to hear from and engage with patient groups and communities who offer us valuable insights into the experiences of those affected by rare diseases

Follow the link to apply on LinkedIn or directly on our website.

For more information about Healx and how we use your data please go to https://healx.ai/privacy/