Quality Assurance Manager

About the Role

Our client is seeking a seasoned and proactive Quality Assurance Manager to lead their quality systems and compliance efforts at their facility in Sunderland . This leadership role is responsible for ensuring that all pharmaceutical products manufactured and distributed adhere to the highest standards of quality, safety, and efficacy, meeting both regulatory and internal requirements. You will manage a team of QA professionals, drive continuous improvement initiatives, and oversee all aspects of the quality management system. This is a critical position for an individual dedicated to upholding product integrity and regulatory compliance in the pharmaceutical sector within Sunderland .

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and other relevant regulations.
• Lead and manage the Quality Assurance team, providing guidance, training, and performance management.
• Oversee internal and external audits, ensuring readiness for regulatory inspections and client audits.
• Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventative actions (CAPAs).
• Review and approve batch records, validation protocols, and other critical quality-related documents.
• Ensure continuous improvement of quality processes and systems to enhance product quality and operational efficiency.

Requirements

• Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology). A Master's degree is a plus.
• Minimum of 6 years of experience in Quality Assurance within the pharmaceutical or related regulated industry.
• Extensive knowledge of GMP regulations (e.g., FDA, EMA, MHRA) and quality system principles.
• Proven experience in managing QA operations, including audits, CAPA systems, and document control.
• Strong leadership, management, and interpersonal skills.
• Excellent analytical, problem-solving, and decision-making abilities.

Benefits

• Competitive salary and comprehensive benefits package.
• Company car or travel allowance.
• Private health insurance and life assurance.
• Pension scheme with generous employer contributions.
• Significant opportunities for career growth and leadership development in Sunderland .
• Relocation assistance may be available for qualified candidates.