At a Glance
- Tasks: Lead quality compliance and ensure regulatory adherence in a dynamic pharmaceutical environment.
- Company: Proclinical, a leading life sciences recruiter with a focus on exceptional talent.
- Benefits: Competitive salary, career growth opportunities, and a chance to make a real impact.
- Other info: Join a collaborative team dedicated to continuous improvement and innovation.
- Why this job: Be at the forefront of quality excellence and regulatory compliance in the pharmaceutical industry.
- Qualifications: Degree in a scientific discipline and strong experience in GMP-regulated environments.
The predicted salary is between 38250 - 46750 £ per year.
Be the force behind audit readiness, regulatory compliance, and sustainable quality excellence.
Proclinical is seeking a Director of Quality & Compliance to lead and oversee the Quality Compliance function at a pharmaceutical site in the UK.
This role focuses on ensuring adherence to regulatory requirements, Gx P standards, and the Quality Management System (QMS).
You will drive compliance strategies, continuous improvement initiatives, and maintain inspection readiness, including for Pre-Approval Inspections (PAIs).
Acting as a key interface with internal and external stakeholders, this position plays a critical role in safeguarding and strengthening quality and compliance standards.
Responsibilities: Serve as the primary contact for regulatory inspections, including preparation, execution, and follow-up on corrective and preventive actions (CAPAs).
Ensure compliance with current Good Manufacturing Practices (c GMP) and Good Laboratory Practices (GLP) across all areas.
Monitor evolving regulatory requirements (e. g., FDA, EMA, MHRA, WHO) and update quality systems and processes accordingly.
Collaborate with senior leadership to address regulatory changes, associated risks, and implement appropriate CAPAs.
Lead internal and external audit programs, including vendor and supplier audits, to assess compliance with standards and expectations.
Develop and maintain the Supplier Management Process.
Oversee document system management and ensure effective Quality Council processes to drive improvements and compliance.
Manage site Quality governance processes, including Periodic Product Reviews, Internal Quality Audits, compliance metrics, and complaints oversight.
Review Quality Risk Models (QRM), identify trends, and implement improvement actions.
Drive continuous improvement initiatives to enhance compliance and operational efficiency. ]Ensure compliance across the product lifecycle, including medical device regulations.
Key Skills and
Requirements: Degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline (advanced degree preferred).
Strong experience in commercial pharmaceutical manufacturing environments with exposure to GMP-regulated operations and quality systems.
Expertise in Product Lifecycle Compliance Management, including compliance strategies across development, commercialization, and post-market activities.
Proven experience leading Quality Compliance programs, including deviation management, CAPA effectiveness, audit readiness, and risk management.
In-depth knowledge of global regulatory and compliance requirements (e. g., c GMP, FDA regulations, ICH Guidelines, WHO standards, Eudra Lex).
Leadership experience managing and developing high-performing teams, with the ability to set priorities and drive accountability.
Excellent communication and stakeholder management skills, with the ability to influence cross-functional teams.
Strong decision-making, analytical, and problem-solving skills, with a focus on continuous improvement.
Experience leading change management initiatives in complex, regulated environments.
If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j. godden@proclinical. com.
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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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Director Quality & Compliance in Stevenage 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 Director Quality & Compliance in Stevenage
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We think you need these skills to ace Director Quality & Compliance in Stevenage
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.
