At a Glance
- Tasks: Lead global quality oversight in pharmacovigilance and regulatory activities for life-saving medicines.
- Company: Join a cutting-edge pharmaceutical team dedicated to operational excellence.
- Benefits: Competitive salary, professional development, and the chance to make a real impact.
- Other info: Foster a culture of continuous improvement and accountability across the organisation.
- Why this job: Shape the future of healthcare while ensuring the highest quality standards.
- Qualifications: Bachelor's in life sciences; strong QA background in pharmaceuticals required.
The predicted salary is between 63000 - 77000 £ per year.
Join a cutting-edge pharmaceutical team where your precision and passion for quality assurance will help shape the future of life-saving medicines!Proclinical is recruiting for an experienced leader with expertise in Pharmacovigilance and Regulatory Affairs to lead global quality oversight activities within a regulated healthcare environment.
The successful candidate will establish and maintain effective quality systems, monitor compliance with international regulatory expectations, and partner with cross-functional teams to strengthen operational excellence.
Key responsibilities include leading quality assessments, supporting health authority inspections, managing CAPA activities, and driving ongoing improvements to quality and compliance.
Responsibilities: Lead and evolve the global quality oversight framework for pharmacovigilance and regulatory activities, partnering with both central and regional teams to promote a consistent and compliant approach.
Design and maintain a forward-looking, risk-based quality review programme, incorporating assessments of internal processes, external service providers, business partners, and affiliate operations.
Coordinate and support regulatory inspections, quality assessments, and due diligence activities, ensuring effective preparation, execution, response management, and follow-up actions.
Drive ongoing monitoring of quality and compliance performance through issue management, corrective action programmes, quality metrics, and governance processes.
Act as a trusted adviser on pharmacovigilance and broader regulated quality requirements, providing guidance to stakeholders across research, development, medical, and commercial functions.
Oversee quality system documentation, governance procedures, safety-related technologies, and outsourced partner relationships to ensure operational effectiveness and regulatory compliance.
Manage departmental planning activities, including budget oversight, resource forecasting, and engagement of specialist contractors or consultants where required.
Track emerging regulatory expectations, industry developments, and best practices, translating insights into practical enhancements that strengthen quality systems and operational excellence.
Foster a culture of continuous improvement, accountability, and quality awareness across the organisation through proactive leadership and stakeholder engagement.
Key Skills and
Requirements: Bachelor's degree in a scientific or life sciences discipline; an advanced degree is preferred.
Strong background in Quality Assurance within the pharmaceutical industry.
Expertise in GVP and GCP regulations, as well as international pharmacovigilance guidelines.
Comprehensive understanding of pharmacovigilance processes, including deviation and CAPA management.
Experience leading global cross-functional teams and managing complex regulatory interactions.
Excellent strategic thinking, decision-making, and problem-solving skills.
Strong communication, negotiation, and influencing abilities across all organizational levels.
Proven ability to manage budgets, resources, and operational plans effectively.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j. godden@proclinical. com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
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Head, PV and Regulatory QA in Maidenhead employer: Proclinical
Proclinical is an exceptional employer dedicated to advancing healthcare through innovative project management. With a strong focus on employee growth, we offer opportunities for professional development and the chance to work on impactful projects within NHS settings across the UK and Ireland. Our collaborative work culture fosters open communication and teamwork, making it a rewarding environment for those looking to make a meaningful difference in the life sciences sector.
StudySmarter Expert Advice🤫
We think this is how you could land Head, PV and Regulatory QA in Maidenhead
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We think you need these skills to ace Head, PV and Regulatory QA in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Proclinical!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Proclinical that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Proclinical!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Proclinical, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Proclinical
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Proclinical that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Proclinical’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
