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, GxP 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 (cGMP) 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., cGMP, FDA regulations, ICH Guidelines, WHO standards, EudraLex).
- 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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