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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
Showcase your leadership skills by participating in relevant projects or initiatives within your current role. Highlight any experience you have in mentoring or coaching teams, as this is crucial for the Lead QP position.
✨Tip Number 3
Familiarise yourself with the specific regulations and guidelines related to radiopharmaceuticals and sterile products. Being well-versed in these areas will demonstrate your commitment and expertise during interviews.
✨Tip Number 4
Prepare to discuss your experience with MHRA inspections and how you've successfully managed compliance issues in the past. This will show that you are ready to take on the responsibilities of a Lead QP.
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 ensuring GMP compliance.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance in the pharmaceutical industry. Mention your experience with radiopharmaceuticals and how you can contribute to the company's quality strategy and team mentorship.
Highlight Relevant Experience: When detailing your work history, focus on your roles that involved QP certification, managing quality teams, and overseeing compliance with UK/EU regulations. Use specific examples to demonstrate your impact in previous positions.
Showcase Leadership Skills: Since this role involves leading a team, be sure to include examples of how you've successfully mentored others, chaired meetings, or contributed to quality management discussions. This will show your readiness for a leadership position.
How to prepare for a job interview at AssureBio
✨Showcase Your Leadership Skills
As a Lead Qualified Person, you'll be expected to manage and mentor teams. Be prepared to discuss your leadership style and provide examples of how you've successfully led teams in the past, particularly in quality assurance settings.
✨Demonstrate Your Regulatory Knowledge
Familiarise yourself with GMP, UK/EU regulations, and local/global procedures. During the interview, highlight your experience with compliance and how you've ensured adherence to these standards in previous roles.
✨Prepare for Technical Questions
Expect questions related to QP certification processes and batch release protocols. Brush up on your technical knowledge regarding radiopharmaceuticals and sterile products to confidently answer any queries that may arise.
✨Emphasise Continuous Improvement
Discuss your approach to fostering a culture of compliance and continuous improvement within quality teams. Share specific initiatives you've implemented that have led to enhanced quality management or operational efficiencies.