Associate Director, Quality Assurance

Cambridge, England, United Kingdom

12/12/2024

Location: Oxford, Cambridge or London ~ hybrid working with a blend of 20-40% in office

About Us

We're a pioneering health tech company that is working to revolutionise healthcare. We're all about helping individuals and those who look after them to make better decisions that improve health, particularly for those common diseases that affect most people and take up most of our precious healthcare resources.

Our secret weapon is genomics - and the unique insight DNA gives us into how our bodies work and sometimes go wrong. We use genomic data to power our tools and platforms, improving every step of the patient pathway. From preventing diseases to improving screening, diagnosing, treatment;, and even developing new medicines.

Our vision is a world where everyone benefits from genomics, helping people to live longer, healthier lives. If that all sounds exciting, join us!

A Day in the Life

This role leads the strategic and operational quality assurance and control efforts at Genomics, ensuring all products and services comply with regulatory requirements and industry standards, particularly for medical devices and in-vitro diagnostics. The Associate Director, Quality Assurance will drive the delivery of reliable, high-quality solutions that enhance product safety, customer satisfaction, and company objectives.

The Quality function supports our Regulatory team and collaborates cross functionally across the business— including with product development, engineering, and operations—to improve the quality management system and address potential risks proactively. The role also involves staying current on quality management trends to keep the company at the forefront of innovation.

What We’re Looking For:

• Ability to develop and execute short- and long-term quality plans to meet organisational needs aligning quality initiatives with business priorities.
• Experienced in implementing and managing ISO 13485:2016 QMS in organisations of all sizes.
• Proven track record in:
• Establishing MDR/IVDR-compliant QMS, including audits for Class IIB+ MD and Class B+ IVD.
• Leading FDA QSR audits.
• Developing IEC 62304-compliant processes to support Agile software development.
• Skilled in aligning quality strategies with diverse business functions (e.g., R&D, SaaS, medical devices) and fostering a culture of quality across all organisational levels, fostering continuous improvement and cohesion.
• Extensive knowledge of UK, EU, and US regulations and standards, with experience in other regions as an asset aligning this with a continuous improvement mindset to stay current with industry standards and best practices.
• Highly desirable: familiarity with ISO 15189:2022 and CLIA/CAP laboratory standards.
  
  

So what's in it for you?

• Salaries: Our salaries are externally benchmarked annually to ensure you receive compensation that aligns with the market.
• Stock options- every team member gets stock options ensuring that everyone reaps the rewards of our collective growth.
• Generous Holiday Allowance: 25 days of annual leave, an additional 3-day company shutdown at the end of the year, plus bank holidays. More time for you to unwind and enjoy.
• Progression - We've got a straightforward and open progression framework that lets you easily see your strengths and areas where you can improve. With this knowledge, you can set personal goals to help you move up the career ladder.
• Invest in Your Future: Take advantage of our training and development opportunities. From regular training courses, to access to a wide range of L&D materials. We're committed to helping you grow and succeed!
• Hybrid Working, Tailored to You: Choose between working in the office and from home. You can be based anywhere in the UK as long as you can get to any one of our offices regularly. As a guide, we expect people to come to the office 2-3 times a week.
• Wellbeing: Join a company that values you not just at work but also outside work. We offer a range of benefits, including comprehensive health insurance for you and your family, critical illness coverage, and life insurance. We also offer enhanced paid family leave.
• Diversity and Inclusion - At Genomics, we wholeheartedly embrace and champion Diversity and Inclusion (D&I) initiatives. We foster an inclusive environment through various means, such as our 'All in Club,' a platform where we come together to celebrate and engage in meaningful discussions about cultural diversity. Additionally, we offer our 'Bank Your Bank Holiday' program, allowing you to exchange public holidays for dates that hold personal or cultural significance to you. It's our way of ensuring that every member of our community feels valued and included.
• Giving Made Easy: Make a difference with our payroll giving scheme. Donate to your favourite charities tax-free and help make the world a better place!
• Green Commute: Join our cycle-to-work scheme and enjoy a healthier, eco-friendly commute. We are also conveniently located by major transport hubs so public transport is a snip. It's good for you and the planet!
• Keeping it social: There are a variety of company socials to enjoy throughout the year, from regular company town halls, team picnics, outdoor summer activities, sports events, and other events organised by our social committee.
  
  

Would you like to learn more? Great, we’d love to chat. Please reach out for more information and to see if this opportunity is right for you!

Genomics is dedicated to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Genomics politely requests no contact from recruitment agencies. We do not accept speculative CVs from recruitment agencies nor accept the fees associated with them.