At a Glance
- Tasks: Ensure GMP compliance and maintain high standards of patient safety across multiple radiopharmacy sites.
- Company: Join Alliance Medical Radiopharmacy UK, a leader in the pharmaceutical industry.
- Benefits: Competitive salary, professional development, and a chance to make a real impact.
- Other info: Dynamic role with opportunities for career advancement and collaboration with top professionals.
- Why this job: Be a key player in regulatory quality assurance and drive excellence in healthcare.
- Qualifications: Degree in Quality or Regulatory discipline with 5+ years of relevant experience.
The predicted salary is between 55000 - 65000 £ 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.
- 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 Quality Assurance Manager employer: Job Search Place Limited
At Alliance Medical Radiopharmacy UK, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through continuous training opportunities and a supportive environment that encourages professional development. Located across multiple licensed radiopharmacy sites, we offer a unique chance to engage with diverse teams while ensuring the highest standards of patient safety and regulatory compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Quality Assurance Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory quality assurance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨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. Confidence is key, so let’s show them what you’ve got!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. We suggest checking out our website for openings that match your skills in regulatory quality assurance. Tailor your approach to each role!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe it shows your enthusiasm and professionalism, which are crucial in the regulatory field.
We think you need these skills to ace Regulatory Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Quality Assurance Manager role. Highlight your experience in GMP, regulatory compliance, and any relevant qualifications. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific experiences that demonstrate your skills in quality assurance and regulatory affairs. Let us know why you’re excited about joining our team!
Showcase Your Communication Skills:Since this role involves engaging with various stakeholders, make sure to showcase your communication skills in your application. Whether it's through your CV or cover letter, we want to see how you can effectively convey complex information.
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. Plus, it shows us you’re keen on joining our team!
How to prepare for a job interview at Job Search Place Limited
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practice (GMP) and the specific expectations of the MHRA. Be ready to discuss how you've ensured compliance in your previous roles, especially in a radiopharmacy or sterile manufacturing environment.
✨Showcase Your Multi-Site Experience
Since this role involves overseeing multiple sites, prepare examples that highlight your experience managing quality assurance across different locations. Talk about how you harmonised quality systems and maintained consistent standards.
✨Engage with Stakeholders
This position requires strong communication skills, so think of instances where you've successfully engaged with both operational and senior stakeholders. Be ready to explain how you navigated these relationships to drive quality initiatives.
✨Be Ready for Regulatory Scenarios
Expect questions about regulatory inspections and authority interactions. Prepare to discuss your experiences with audits, inspections, and how you've handled follow-up commitments. This will show your proactive approach and attention to detail.
