Pharmaceutical Quality Assurance Manager

About the Role

Our client is looking for an experienced and detail-oriented Pharmaceutical Quality Assurance Manager to lead their Quality Assurance department in Cardiff . This senior role is responsible for developing, implementing, and maintaining the company's quality management system (QMS) to ensure compliance with all relevant regulatory standards, including GMP. You will play a critical role in safeguarding product quality, driving continuous improvement initiatives, and fostering a strong quality culture across the organization. This is an opportunity to shape the quality strategy within a growing pharmaceutical company and contribute to the delivery of safe and effective medicines.

Key Responsibilities

• Develop, implement, and manage the overall Quality Management System (QMS) in accordance with GMP and other relevant regulations.
• Oversee and conduct internal audits and support external regulatory inspections and customer audits.
• Manage deviations, CAPAs, change controls, and risk assessments, ensuring timely and effective resolution.
• Review and approve critical quality documents, including batch records, specifications, and validation protocols.
• Lead and mentor the Quality Assurance team, fostering their professional development.
• Act as the primary point of contact for all QA-related regulatory inquiries and compliance matters.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Significant experience (e.g., 7+ years) in Quality Assurance within the pharmaceutical industry.
• Thorough knowledge of GMP regulations (e.g., EU GMP, FDA) and quality systems.
• Proven experience in managing QMS processes, including audits, deviations, and CAPA systems.
• Strong leadership, decision-making, and problem-solving skills.
• Excellent understanding of pharmaceutical manufacturing processes and controls.

Benefits

• Highly competitive salary and bonus structure.
• Comprehensive benefits package including private medical insurance, life assurance, and pension contributions.
• Significant opportunities for career growth and leadership development in Cardiff .
• Relocation assistance may be available for suitable candidates.
• A commitment to employee well-being and work-life balance.