At a Glance
- Tasks: Certify pharmaceutical batches and ensure compliance with regulations.
- Company: Global pharmaceutical organisation focused on quality and patient safety.
- Benefits: Competitive salary, benefits package, and opportunities for professional growth.
- Why this job: Be the legal authority ensuring safe medicines reach patients.
- Qualifications: Experience as a Qualified Person in regulated environments required.
- Other info: On-site role with close collaboration across teams in London.
The predicted salary is between 72000 - 84000 £ per year.
We are supporting a global pharmaceutical organisation operating in highly regulated UK and EU markets, seeking a Qualified Person (QP) to take full legal and technical ownership of batch certification, GMP compliance, and regulatory alignment across UK and European operations. This is a hands-on, accountable QP role where you act as the final legal authority between manufacturing and patient release.
What You'll Be Accountable For:
- Batch Certification & Manufacturing Oversight: Legally certify pharmaceutical batches in line with UK law and EU Directives. Ensure manufacturing and testing activities comply with GMP and Marketing Authorisations. Oversee internal and third-party manufacturing partners.
- Quality Systems & Compliance Leadership: Own and maintain the Quality Management System (QMS). Lead governance of: Deviations, CAPAs, Change Controls, Risk Assessments, Annual Product Reviews (APR), Self-Inspections & Audits.
- Regulatory & Authority Engagement: Act as a senior quality interface with MHRA and EU regulatory bodies. Support inspections, manufacturing line approvals, and regulatory submissions.
- Cross-Functional Leadership: Partner with QA, Manufacturing, Regulatory Affairs, and Supply Chain teams. Lead GMP training and SOP development across UK/EU operations.
- Quality Risk & Patient Safety: Own recall processes and escalation pathways. Proactively identify and mitigate quality risks impacting patient safety.
Must-Haves (Non-Negotiable):
- Eligible to act as a Qualified Person under UK law (Directive *******/EC).
- 4–5+ years operating as a named QP in regulated pharmaceutical environments.
- Degree in Pharmacy, Chemistry, Biology, or related life sciences.
- Deep hands-on experience with: GMP manufacturing operations; Batch certification and regulatory documentation; Pharmaceutical Quality Systems.
- Experience within large or multi-site pharmaceutical organisations.
Nice-to-Haves:
- UK/EU multi-site manufacturing oversight.
- Third-party manufacturer and Quality Agreement management.
- Regulatory audit leadership.
Work Environment:
- On-site role spanning manufacturing facilities and corporate quality office (London).
- Close collaboration with production, QA, regulatory, and leadership teams.
- 2–3 stage interview process, including technical and compliance assessment.
Compliance & Eligibility:
- UK Citizens / Permanent Right to Work required.
- Notice Period: ***** days preferred.
Application Process:
To apply, please submit your CV and a cover letter detailing your relevant experience and qualifications for the role. Applications will be reviewed on a rolling basis, so early submissions are encouraged.
Equal Opportunity Employer: We value diversity and are committed to creating an inclusive work environment. We encourage applicants from all backgrounds to apply.
Contact: Elvis Eckardt
Qualified Person in England employer: Elvis Eckardt Recruitment
Contact Detail:
Elvis Eckardt Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality assurance or manufacturing. A friendly chat can lead to insider info about job openings that might not even be advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your GMP knowledge and regulatory compliance. We recommend doing mock interviews with friends or colleagues to get comfortable discussing your experience and how it aligns with the role of a Qualified Person.
✨Tip Number 3
Showcase your hands-on experience! During interviews, share specific examples of how you've managed batch certification and compliance in previous roles. This will demonstrate your expertise and make you stand out as a candidate.
✨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 Qualified Person in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Qualified Person role. Highlight your experience in GMP compliance, batch certification, and any relevant regulatory work. 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. Share specific examples of your past experiences that relate to the responsibilities listed in the job description. We love a good story!
Showcase Your Leadership Skills: Since this role involves cross-functional leadership, don’t forget to showcase your leadership skills in both your CV and cover letter. Talk about times you’ve led teams or projects, especially in regulated environments. We’re all about collaboration!
Apply Early Through Our Website: We review applications on a rolling basis, so don’t wait too long to apply! Head over to our website to submit your application. The sooner you get your materials in, the better your chances are of standing out to us!
How to prepare for a job interview at Elvis Eckardt Recruitment
✨Know Your Regulations
Make sure you brush up on UK and EU regulations related to batch certification and GMP compliance. Being able to discuss specific directives and how they apply to the role will show that you're not just familiar with the requirements, but that you can navigate them confidently.
✨Showcase Your Experience
Prepare to share detailed examples from your past roles where you've successfully managed quality systems or led audits. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easy for the interviewers to see your impact.
✨Engage with Cross-Functional Teams
Since this role involves collaboration with various departments, think of instances where you've worked with QA, manufacturing, or regulatory teams. Highlight your ability to lead training sessions or develop SOPs, as this will demonstrate your leadership skills and teamwork.
✨Prepare for Technical Questions
Expect technical questions related to quality risk management and patient safety. Brush up on recall processes and risk assessments, and be ready to discuss how you've handled similar situations in the past. This will help you stand out as a knowledgeable candidate.