At a Glance
- Tasks: Ensure GMP compliance and oversee quality assurance across multiple radiopharmacy sites.
- Company: Join Alliance Medical Radiopharmacy UK, a leader in patient safety and operational excellence.
- Benefits: Competitive salary, professional development, and the chance to make a real impact.
- Other info: Dynamic role with opportunities for growth and collaboration across multiple sites.
- Why this job: Be a key player in maintaining high standards of quality and regulatory readiness.
- Qualifications: 5+ years in regulatory QA, ideally in radiopharmacy or sterile manufacturing.
The predicted salary is between 60000 - 75000 £ per year.
We are looking for a highly skilled Regulatory Quality Assurance Manager to join Alliance Medical Radiopharmacy UK. Sitting within our UK Quality function, this role reports directly to the Head of Quality UK and plays a key part in ensuring GMP and regulatory compliance across our network of seven licensed radiopharmacy sites. You will act as a central link between Quality Assurance, Regulatory Affairs, Operations and external regulatory authorities, helping us maintain the highest standards of patient safety, operational excellence and regulatory readiness.
We're looking for someone with a strong background in regulatory quality assurance within a pharmaceutical or radiopharmaceutical environment. You will be confident operating across multiple sites and engaging with stakeholders at operational and senior levels.
Qualifications
- Degree or equivalent experience in Quality, Regulatory, or a pharmaceutical discipline.
- Minimum of 5 years' regulatory experience, ideally within radiopharmacy, sterile manufacturing or aseptic processing.
- Proven experience with GMP, MHRA expectations and broader GxP requirements.
- Experience supporting commercial and IMP product development, including clinical trial supply.
- Strong understanding of regulatory inspections and authority interactions.
- Experience working across multi site operations with consistent quality standards.
- Excellent communication, organisational and interpersonal skills.
- Strong attention to detail, proactive approach and ability to work independently.
- Proficiency in Microsoft Word, Excel, PowerPoint and general Windows applications.
Key Responsibilities
- Overseeing GMP, GDP and MHRA compliance across multiple radiopharmacy sites.
- Acting as QA regulatory lead for Commercial and IMP activities, including IMPD reviews and clinical trial processes.
- Supporting MHRA and regulatory authority interactions, including inspections, audits and follow up commitments.
- Maintaining site licences, variations and regulatory submissions in line with operational needs.
- Harmonising quality systems across sites, including deviations, CAPAs, change control and documentation.
- Providing QA input into product development, validation and technology transfer activities.
- Reviewing and approving key documentation such as SOPs, validation protocols and batch records.
- Contributing to the implementation of a new electronic QMS.
- Driving inspection readiness and a strong quality culture across the UK network.
- Deputising for the Head of Quality when required.
Regulatory QA Lead – Radiopharma (Multi-Site) employer: Job Search Place Limited
Alliance Medical Radiopharmacy UK is an exceptional employer that prioritises patient safety and operational excellence within a collaborative and supportive work environment. With a strong focus on employee growth, we offer opportunities for professional development and engagement across our multi-site operations, ensuring that our team members are equipped to excel in their roles. Join us to be part of a dynamic culture that values quality assurance and regulatory compliance, making a meaningful impact in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory QA Lead – Radiopharma (Multi-Site)
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory QA field on LinkedIn or at industry events. Engaging with others can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and MHRA standards. We recommend creating a list of common interview questions and practising your responses, especially around compliance and quality assurance.
✨Tip Number 3
Showcase your multi-site experience! Be ready to discuss how you've managed quality across different locations. Use specific examples to highlight your ability to harmonise quality systems and maintain standards.
✨Tip Number 4
Don’t forget to 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 Regulatory QA Lead – Radiopharma (Multi-Site)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experience mentioned in the job description. Highlight your regulatory QA experience, especially in radiopharmacy or sterile manufacturing, to show us you’re the right fit for the role.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you’re passionate about regulatory quality assurance. Share specific examples of how you've ensured GMP compliance and engaged with stakeholders, as this will help us see your potential impact on our team.
Showcase Your Communication Skills:Since this role involves liaising with various teams and external authorities, make sure your application demonstrates your excellent communication and interpersonal skills. We want to know how you’ve effectively communicated complex regulatory requirements in the past.
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 don’t miss out on any important updates during the process. Plus, it shows us you’re keen to join our team!
How to prepare for a job interview at Job Search Place Limited
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of GMP, MHRA expectations, and GxP requirements. Be ready to discuss how your experience aligns with these standards, especially in a radiopharmaceutical context. This will show that you’re not just familiar with the regulations but can also apply them effectively.
✨Showcase Your Multi-Site Experience
Since this role involves overseeing multiple sites, be prepared to share specific examples of how you've managed quality assurance across different locations. Highlight any challenges you faced and how you overcame them, as well as how you ensured consistent quality standards throughout.
✨Engage with Stakeholders
This position requires interaction with various stakeholders, so practice articulating your communication style. Think of examples where you successfully collaborated with both operational teams and senior management. Demonstrating your interpersonal skills will be key to showing you can bridge gaps between departments.
✨Prepare for Regulatory Interactions
Familiarise yourself with the inspection processes and authority interactions you've been involved in. Be ready to discuss how you’ve handled audits or inspections in the past, including any follow-up commitments. This will illustrate your proactive approach and readiness to maintain compliance.
