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- Tasks: Lead the Quality Assurance team and ensure top-notch quality in biotech operations.
- Company: Innovative biotech company revolutionising DNA synthesis in Cambridge.
- Benefits: Competitive salary, private pension, share incentives, and career progression.
- Why this job: Join a pioneering team making a real impact in biotechnology and gene therapy.
- Qualifications: 5+ years in QA leadership within biotech, with strong GMP knowledge.
- Other info: Dynamic environment with opportunities for professional growth and mentorship.
The predicted salary is between 60000 - 84000 £ per year.
Location: Cambridge
Contract: Full-time and permanent - onsite
Sector: Biotechnology and gene therapy
Salary: c£70,000 - £90,000 depending on experience and interview performance
Our client is an innovative biotechnology company based outside of the centre of Cambridge. They have built a platform to synthesise DNA, providing exciting possibilities for ensuring cheaper, faster and more accurate DNA / gene constructs than traditional plasmid-based methods. In a key phase of their growth, our client is looking to expand their Quality Assurance team by hiring a Head of Quality (reporting to the VP of Quality). If you are an experienced QA Lead within the biotech MSAT and CMC GMP sector, this may be an opportunity of interest.
This is an opportunity for a proven Quality Assurance leader with 5+ years’ of management experience within a biotechnology / gene therapy / cell therapy GMP setting. You will have experience in CMC, MSAT and tech transfer to manufacturing. This role will involve the following:
- Managing the Quality Operations team, including a QA Manager and other staff members.
- Taking ownership of Quality Assurance operations for all CMC, MSAT and manufacturing functions of the business. You will also develop and implement new quality initiatives to ensure smooth transition of products from R&D to manufacturing.
- Acting as point of contact for clients with respect to GMP quality and FDA / EU regulatory related queries. This will be a client facing position.
- Supporting external quality audits and leading internal audits for quality processes.
- Overseeing and managing the GMP QMS, designing and implementing new processes; alongside promoting best practices and suggesting improvements.
- Training of staff within the Quality Operations team.
The ideal candidate will have the following:
- BSc / MSc / PhD in a life science discipline (essential, or equivalent experience)
- Must have several years of experience in leading Quality Operations (leading both teams and operations) for a biotechnology / cell therapy / gene therapy organisation. Must have the mentality to mentor and grow employees within the team (essential)
- Expert knowledge of GMP quality for biotechnology or gene therapy operations built over many years’ experience (essential)
- Must have proven experience in Quality assurance for Chemistry Manufacturing Control (CMC) and Manufacturing, Science & Technology (MSAT) and Tech Transfer + Process Development operations (essential)
- Experience in creating, maintaining and updating a Quality Management System (QMS) and relevant documents including deviation investigation, CAPAs, change control, non-conformance etc (essential)
- Understanding of regulatory requirements for APIs in drug development (MHRA, FDA etc) (essential)
- High attention to detail, the drive to be a complete finisher and highly organised (essential)
- Good communication skills (essential)
- Prior lead auditor experience (desired)
- Must have full, long-term right to work in the UK (essential)
As an up-and-coming Cambridge Biotech, our client is able to offer a competitive salary, progression options and benefits package including private pension and share incentives.
Head Of Quality Assurance in Cambridge employer: Taylorollinson
Contact Detail:
Taylorollinson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head Of Quality Assurance in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech sector, especially those who work in quality assurance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and regulatory requirements. We all know that confidence is key, so practice answering common QA questions and be ready to showcase your leadership experience.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Head Of Quality Assurance in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Head of Quality Assurance role. Highlight your experience in Quality Operations, especially in biotech or gene therapy settings. We want to see how your background aligns with the specific skills mentioned in the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention your management experience and how you've successfully led teams in Quality Assurance. Remember, we love a good story!
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just responsibilities. Did you implement a new quality initiative that improved processes? Share those successes with us! Numbers and specific examples can really make your application stand out.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Taylorollinson
✨Know Your Stuff
Make sure you brush up on your knowledge of GMP quality standards and the specifics of CMC and MSAT processes. Being able to discuss these topics confidently will show that you're not just familiar with the theory, but that you can apply it in practice.
✨Showcase Your Leadership Skills
As a Head of Quality Assurance, you'll be managing a team. Prepare examples of how you've successfully led teams in the past, particularly in a biotech setting. Highlight your mentoring approach and how you've developed others in your previous roles.
✨Prepare for Client Interactions
Since this role involves client-facing responsibilities, think about how you would handle regulatory queries or audits. Be ready to discuss your experience in these areas and how you ensure compliance while maintaining strong client relationships.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company's quality initiatives and future plans. This shows your genuine interest in the role and helps you assess if the company aligns with your career goals.
