Quality Assurance Manager

About the Role

Our client is seeking an accomplished and strategic Quality Assurance Manager to lead their Quality Unit, operating in a remote-first capacity to support their operations near Sunderland . This critical role ensures that all pharmaceutical products manufactured and distributed meet the highest standards of quality, safety, and efficacy, adhering strictly to regulatory requirements. You will be responsible for developing and implementing robust quality management systems, leading audits, and fostering a company-wide culture of quality excellence. This is a senior position for a leader passionate about maintaining compliance and driving continuous improvement in a demanding pharmaceutical landscape.

Key Responsibilities

• Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with GMP and other relevant regulatory standards.
• Lead and conduct internal and external audits of suppliers, manufacturing partners, and internal processes.
• Manage and investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing effective CAPA plans.
• Oversee product release processes, ensuring all quality control checks and documentation are complete and satisfactory.
• Provide quality oversight and support for product development, manufacturing, and commercialization activities.
• Mentor and develop the quality assurance team, promoting a strong quality culture across the organization.

Requirements

• Degree in Pharmacy, Chemistry, Biology, or a related scientific field; advanced degree preferred.
• Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance or Quality Control.
• In-depth knowledge of Good Manufacturing Practices (GMP) , regulatory guidelines (e.g., MHRA, FDA, EMA), and quality management principles.
• Proven experience in managing quality systems, conducting audits, and leading investigations.
• Strong leadership, decision-making, and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.

Benefits

• Highly competitive executive salary and bonus structure.
• Fully remote working arrangement, providing excellent work-life integration.
• Comprehensive executive health, dental, and vision insurance.
• Generous stock options and long-term incentive plans.
• Opportunities to shape the quality strategy for a growing pharmaceutical company.