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- Tasks: Lead a team of QPs ensuring compliance and quality in radiopharmaceutical manufacturing.
- Company: Join a dynamic pharmaceutical company focused on innovative radiopharmaceutical products.
- Benefits: Enjoy competitive salary, leadership opportunities, and a supportive work culture.
- Why this job: Shape quality strategy and mentor teams while making a real impact in healthcare.
- Qualifications: 10+ years in Quality Assurance and 5+ years managing teams in a pharmaceutical setting.
- Other info: Eligible candidates must be named as a Qualified Person on a manufacturing licence.
The predicted salary is between 60000 - 84000 £ per year.
Are you an experienced Qualified Person (QP) looking to take the next step in your career? Do you thrive in leadership roles where you can shape quality strategy, mentor teams, and ensure the highest standards of GMP compliance? We are recruiting for a Lead Qualified Person to take on a leadership role within a dynamic pharmaceutical environment, overseeing a team of QPs and quality management in radiopharmaceutical manufacturing.
About the Role
As a Lead QP, you will play a critical role in ensuring the safe release of radiopharmaceutical products across multiple sites in the UK. You will be responsible for:
- Managing and leading a team of permanent and contract Qualified Persons (QPs) across multiple UK manufacturing sites.
- Acting as a Releasing QP for radiopharmaceuticals/sterile products under a UK MHRA licence.
- Chairing the QP Forum and contributing to site Quality Management Meetings.
- Ensuring compliance with GMP, UK/EU regulations, and local/global procedures.
- Reviewing and certifying batches in a timely manner while overseeing deviations, complaints, CAPAs, and OOS/OOT investigations.
- Supporting MHRA inspections at key manufacturing sites.
- Acting as a mentor and coach for quality teams, fostering a culture of compliance and continuous improvement.
- Working closely with the Head of Quality to enhance and maintain the Global Quality System.
Experience & Qualifications
- Eligible to be named as a Qualified Person (QP) on a manufacturing licence.
- 10+ years’ Quality Assurance experience within a UK-licensed pharmaceutical organisation.
- 5+ years’ experience managing Quality teams in Quality Assurance or Quality Control.
- Previous experience in QP certification of medicinal products.
- Background in pharmaceutical manufacturing, preferably in sterile or radiopharmaceutical production.
Lead Qualified Person (QP) employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Qualified Person (QP)
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who are already working as Qualified Persons. Attend industry conferences or seminars to meet potential colleagues and learn about the latest trends in GMP compliance.
✨Tip Number 2
Consider joining relevant professional organisations or forums where you can engage with other QPs. This will not only enhance your knowledge but also increase your visibility within the community, making it easier for us to notice you.
✨Tip Number 3
Stay updated on the latest UK/EU regulations and guidelines related to radiopharmaceuticals and GMP compliance. Demonstrating your knowledge during interviews can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your leadership style and experiences in managing quality teams. We value candidates who can demonstrate their ability to mentor and foster a culture of compliance, so be ready to share specific examples.
We think you need these skills to ace Lead Qualified Person (QP)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience as a Qualified Person (QP) and your leadership skills. Emphasise your 10+ years in Quality Assurance and any specific achievements in managing teams or improving compliance.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality management in the pharmaceutical industry. Mention your experience with GMP compliance and how you can contribute to the company's goals, particularly in radiopharmaceutical manufacturing.
Highlight Relevant Experience: When detailing your work history, focus on roles where you acted as a Releasing QP or managed Quality teams. Include specific examples of how you've overseen deviations, complaints, and CAPAs, showcasing your problem-solving skills.
Showcase Leadership Qualities: Since this role involves mentoring and coaching, provide examples of how you've successfully led teams in the past. Discuss your approach to fostering a culture of compliance and continuous improvement within your previous organisations.
How to prepare for a job interview at AssureBio
✨Showcase Your Leadership Experience
As a Lead Qualified Person, you'll be expected to manage and mentor teams. Be prepared to discuss your previous leadership roles, how you motivated your team, and any specific strategies you implemented to enhance performance and compliance.
✨Demonstrate Your Regulatory Knowledge
Familiarise yourself with GMP, UK/EU regulations, and local/global procedures. During the interview, highlight your experience in ensuring compliance and how you've handled inspections or audits in the past.
✨Prepare for Technical Questions
Expect questions related to QP certification processes, batch review, and handling deviations. Brush up on your technical knowledge and be ready to provide examples of how you've successfully navigated these challenges in your previous roles.
✨Emphasise Continuous Improvement
The role involves fostering a culture of compliance and improvement. Share specific instances where you've implemented changes that led to better quality outcomes or enhanced team performance, showcasing your commitment to ongoing development.
