Quality Assurance Manager

About the Role

Our client is seeking a highly experienced Quality Assurance Manager to lead their QA operations in Sunderland . This senior position is responsible for establishing and maintaining the company's Quality Management System (QMS) to ensure compliance with pharmaceutical industry standards and regulatory requirements. You will oversee all QA activities, including audits, deviations, change control, and CAPA management, fostering a strong quality culture throughout the organization. Your leadership will be critical in ensuring the safety, efficacy, and quality of our client's pharmaceutical products manufactured and distributed from the Sunderland facility.

Key Responsibilities

• Develop, implement, and manage the company's Quality Management System (QMS) in compliance with cGMP and other relevant regulations.
• Lead and conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
• Oversee the investigation of deviations, out-of-specifications (OOS) results, and customer complaints, ensuring timely resolution and implementation of corrective actions.
• Manage the change control process, assessing the impact of proposed changes on product quality and regulatory compliance.
• Review and approve batch records, validation protocols, and other critical quality documentation.
• Train and mentor QA personnel, fostering a strong understanding and commitment to quality principles across the site.

Requirements

• Bachelor's or Master's degree in a scientific or technical field (e.g., Pharmacy, Chemistry, Engineering).
• Minimum of 7 years of progressive experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of cGMP regulations, ICH guidelines, and Quality Risk Management principles.
• Proven experience in leading QA teams and managing QA operations.
• Strong understanding of pharmaceutical manufacturing processes, validation, and control strategies.
• Excellent leadership, communication, and interpersonal skills, with the ability to influence stakeholders at all levels.

Benefits

• Competitive salary and bonus structure reflective of experience and responsibilities.
• Comprehensive health, dental, and vision insurance.
• Pension scheme with employer contributions.
• Opportunities for professional growth and development within a leading pharmaceutical company in Sunderland .
• Supportive work environment with a strong emphasis on quality and compliance.