Pharmaceutical Quality Assurance Manager

About the Role

Our client seeks a highly motivated and experienced Pharmaceutical Quality Assurance Manager to lead their Quality Unit in Milton Keynes . This senior position is responsible for establishing, implementing, and maintaining the company's quality management system, ensuring compliance with all relevant regulatory standards and guidelines. You will play a crucial role in driving continuous improvement across all operational areas, safeguarding product quality and patient safety. This is an excellent opportunity for a seasoned QA professional to make a significant impact within a growing pharmaceutical organization, contributing to the high standards of quality expected from the UK's life sciences sector.

Key Responsibilities

• Develop, implement, and manage the Quality Management System (QMS) in compliance with GMP, GDP, and other relevant regulations.
• Oversee all quality assurance activities, including internal and external audits, CAPA management, and deviation investigations.
• Ensure that all manufacturing, laboratory, and distribution processes meet regulatory requirements and company standards.
• Lead and mentor the Quality Assurance team, fostering a culture of quality awareness and continuous improvement.
• Review and approve key quality-related documentation, such as batch records, validation reports, and SOPs.
• Act as the primary contact for regulatory inspections and ensure successful outcomes.

Requirements

• Master's degree or higher in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Engineering).
• Extensive experience (7+ years) in a Quality Assurance role within the pharmaceutical industry.
• Demonstrated knowledge of GMP, GDP, and regulatory requirements from agencies like MHRA, FDA, and EMA.
• Proven experience in leading and managing QA teams and implementing quality systems.
• Strong understanding of pharmaceutical manufacturing processes, validation, and quality control.
• Excellent leadership, strategic thinking, and problem-solving skills .

Benefits

• Highly competitive salary package with comprehensive bonus structure.
• Executive-level health, dental, and vision insurance.
• Generous employer contribution to pension fund.
• Significant opportunities for career advancement and professional development.
• Flexible working arrangements available, supporting a remote-first approach from Milton Keynes .