At a Glance
- Tasks: Lead Quality Assurance, Control, and Validation in a fast-paced cell therapy manufacturing environment.
- Company: Specialist CDMO near Cambridge with a focus on innovative therapies.
- Benefits: Competitive salary, leadership role, and opportunity to shape quality standards.
- Other info: Join a dynamic team with a strong focus on operational excellence.
- Why this job: Make a significant impact in the evolving field of cell therapies.
- Qualifications: Significant ATMP experience and proven leadership in QA, QC, and Validation.
The predicted salary is between 80000 - 100000 £ per year.
We're partnering exclusively with a specialist CDMO based near Cambridge to appoint their next Head of Quality, the most senior Quality role in the business, reporting directly to the company President. The Quality leader will take full ownership of Quality Assurance, Quality Control and Validation across a licensed, GMP-regulated cell therapy manufacturing environment, overseeing a combined team of approximately 30 people across three functions. The organisation holds MIA, MIA(IMP), and HTA licences, operates Grade B cleanrooms, and manufactures autologous cell therapies at commercial and clinical scale. An MHRA inspection is anticipated in the near term. This is an operationally demanding environment that moves fast and expects its Quality leader to move with it.
The scope of the role:
- Full leadership of QA (11–12 staff), QC (12–13 staff) and Validation (5 staff)
- Named as person responsible for QC on the MHRA site licence
- Ownership of QMS, eQMS, contamination control strategy and inspection readiness
- Driving batch release, deviation management, CAPA, CCS and validation programmes
- Likely responsibility for a MasterControl eQMS implementation
- Key member of the site leadership team working alongside Operations and the President
What they're looking for:
- Significant ATMP experience - cell therapy strongly preferred, viral vector or advanced biologics considered
- Proven leadership of QA, QC and Validation together - not just one function
- Deep sterile manufacturing knowledge - Grade A/B cleanrooms, contamination control, CCS
- MHRA inspection experience, ideally in a licensed manufacturing environment
- MSc or PhD in a life sciences discipline preferred
- Commercial mindset - CDMO, commercial biotech or manufacturing-led organisation
Head of Quality - CDMO employer: AssureBio
This specialist CDMO near Cambridge offers an exceptional work environment for the Head of Quality, where you will lead a dedicated team in a fast-paced, GMP-regulated setting. With a strong focus on employee development and a culture that values innovation and collaboration, you will have the opportunity to make a significant impact on the quality of cutting-edge cell therapies. The company also provides competitive benefits and is committed to maintaining a supportive atmosphere that fosters professional growth and excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality - CDMO
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We think you need these skills to ace Head of Quality - CDMO
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at AssureBio!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show AssureBio that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at AssureBio!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At AssureBio, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at AssureBio
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at AssureBio that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with AssureBio’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
