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- Tasks: Lead a team of Qualified Persons ensuring compliance in radiopharmaceutical manufacturing.
- Company: Join a dynamic pharmaceutical company focused on quality and innovation.
- Benefits: Enjoy a full-time role with opportunities for mentorship and professional growth.
- Why this job: Shape quality strategy and make a real impact in the pharmaceutical industry.
- Qualifications: 10+ years in Quality Assurance and 5+ years managing teams required.
- Other info: Eligible candidates must be named as a Qualified Person on a manufacturing licence.
The predicted salary is between 54000 - 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.Seniority Level Mid-Senior levelEmployment Type Full-timeJob Function Quality AssuranceIndustries Pharmaceutical Manufacturing
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Lead Qualified Person employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Qualified Person
✨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 quality assurance.
✨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 will be crucial for the Lead QP position.
✨Tip Number 3
Familiarise yourself with the specific regulations and compliance standards related to radiopharmaceuticals. Being well-versed in these areas will demonstrate your commitment to quality and safety in your application.
✨Tip Number 4
Prepare to discuss your experience with MHRA inspections and how you've successfully navigated compliance challenges 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
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience as a Qualified Person, particularly focusing on your leadership roles and any specific achievements in quality assurance within the pharmaceutical sector. Use keywords from the job description to align your experience with what they are looking for.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and leadership. Discuss your experience managing teams and ensuring GMP compliance, and how you can contribute to their quality strategy. Be sure to mention your eligibility as a Qualified Person and any relevant certifications.
Showcase Relevant Experience: When detailing your work history, focus on your 10+ years of Quality Assurance experience and your 5+ years managing teams. Highlight specific projects or initiatives where you improved compliance or mentored team members, as these will resonate with the hiring team.
Proofread Your Application: Before submitting, carefully proofread your application materials. Look for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in the pharmaceutical industry.
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 a team. 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.
✨Emphasise Continuous Improvement
Discuss your approach to fostering a culture of compliance and continuous improvement within your teams. Share specific examples of initiatives you've implemented that have enhanced quality systems or processes.
