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- Tasks: Lead quality assurance for radiopharmaceuticals and ensure compliance with GMP regulations.
- Company: Join a leading pharmaceutical organisation shaping the future of healthcare in the UK.
- Benefits: Competitive salary, career development opportunities, and a chance to make a real impact.
- Why this job: Be at the forefront of quality in pharmaceuticals and drive excellence across UK operations.
- Qualifications: 5+ years in a managerial role within a pharmaceutical Quality Department required.
- Other info: Dynamic environment with opportunities for growth and collaboration across teams.
The predicted salary is between 36000 - 60000 £ per year.
Lead with integrity, certify with precision - shape the future of radiopharmaceutical quality across the UK. R&D Partners is seeking an experienced and driven Country Quality Lead & Qualified Person (QP) to join a leading pharmaceutical organization in the UK. This critical leadership role involves ensuring compliance with UK and EU GMP regulations, overseeing site-level quality assurance and control activities, and providing QP certification and batch release of radiopharmaceuticals. The ideal candidate will partner closely with operations, regulatory, and corporate teams to maintain the highest standards of quality, safety, and compliance across UK operations. Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Ensure all operational activities across UK sites comply with current Good Manufacturing Practices (cGMP), legal and regulatory requirements, and the corporate quality management system.
- Establish and maintain a robust quality organization within the UK to support compliance and operational excellence.
- Oversee quality programs, documentation, reporting, incident management, and escalation processes to ensure timely and GMP-compliant decision-making.
- Lead inspection readiness efforts and ensure successful outcomes of Health Authority inspections across all UK sites.
- Provide strategic and technical leadership for quality operations across all UK sites.
- Conduct annual audits of UK manufacturing sites to verify adherence to national and corporate quality standards.
- Monitor and evaluate site quality performance using defined Key Quality Indicators (KQIs) to drive continuous improvement.
- Support drafting and revising Quality Agreements with Contract Givers/Acceptors in collaboration with the Corporate Quality Department.
- Actively participate in inspections by regulatory authorities (e.g., MHRA) and external auditors, including follow-up and remediation activities.
- Oversee supplier qualification activities, including audits and ongoing compliance monitoring.
- Lead customer complaint investigations in coordination with the Corporate Quality Department.
- Escalate significant Quality/cGMP issues to the International Quality Head and relevant stakeholders.
- Conduct Quality Assessments across national sites, ensuring timely cGMP-compliant decision-making and follow-up.
- Drive corrective and preventive actions based on QA performance reports.
- Contribute to recruitment, training, and development of Quality personnel across UK sites.
Key Skills and Requirements:
- Minimum of 5 years of experience in a managerial role within a pharmaceutical Quality Department.
- Demonstrated leadership capabilities with the ability to guide and develop quality teams.
- Strong organizational skills, including time management, risk management, and prioritization.
- In-depth knowledge of GMP and ISO quality systems and standards.
- Solid understanding of national and international regulatory requirements relevant to radiopharmaceutical manufacturing.
- Excellent communication skills to collaborate effectively across departments and with external partners.
Country Quality Lead & QP employer: R&D Partners
Contact Detail:
R&D Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Country Quality Lead & QP
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality assurance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your GMP knowledge and recent regulatory changes. We want you to showcase your expertise and confidence when discussing compliance and quality management.
✨Tip Number 3
Don’t just wait for job alerts; actively search for roles on our website. We regularly update listings, and applying directly can give you an edge over other candidates.
✨Tip Number 4
Follow up after interviews with a thank-you email. It’s a simple gesture that shows your enthusiasm for the role and keeps you fresh in the interviewer's mind.
We think you need these skills to ace Country Quality Lead & QP
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Country Quality Lead & QP role. Highlight your managerial experience in a pharmaceutical Quality Department and any relevant GMP knowledge to catch our eye!
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 your passion for quality assurance and how you can contribute to maintaining high standards across UK operations.
Showcase Your Leadership Skills: We’re looking for someone who can lead and develop quality teams. In your application, give examples of how you've successfully guided teams in the past and how you plan to do the same with us at StudySmarter.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at R&D Partners
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and how they apply specifically to radiopharmaceuticals. Be ready to discuss how you've ensured compliance in previous roles, as this will show your expertise and commitment to quality.
✨Showcase Your Leadership Skills
As a Country Quality Lead, you'll need to demonstrate strong leadership capabilities. Prepare examples of how you've guided and developed quality teams in the past. Think about specific challenges you faced and how you overcame them to maintain high standards.
✨Be Ready for Scenario Questions
Expect scenario-based questions that test your problem-solving skills in quality assurance. Practice articulating your thought process when dealing with compliance issues or during inspections. This will help you convey your strategic thinking and decision-making abilities.
✨Communicate Effectively
Since collaboration is key in this role, practice your communication skills. Be prepared to discuss how you've worked with cross-functional teams and external partners. Highlight your ability to convey complex information clearly and effectively, as this will be crucial in ensuring compliance and operational excellence.