Head of Quality - #2174725

Head of Quality - Manchester - On-Site

I am currently working with an established parallel imports pharmaceutical organization in Manchester that operates across pharmaceutical manufacturing, licensing and medicines supply. This is an excellent opportunity for an experienced Quality leader to take ownership of site-wide Quality operations, drive continuous improvement initiatives, and ensure the highest standards of GMP compliance across the business.

Key Responsibilities:

• Provide strategic and operational leadership for a fast-paced parallel import company, managing a department of QA and 7 in QC employees.
• Develop and implement site quality strategies aligned with business objectives and regulatory expectations.
• Act as the primary quality representative for internal stakeholders, customers and regulatory authorities.
• Lead regulatory, customer and internal inspections, ensuring inspection readiness at all times.
• Maintain and enhance Quality Management Systems in line with GMP and relevant pharmaceutical regulations.
• Oversee risk management processes, ensuring quality and compliance risks are proactively identified and controlled.
• Drive continuous improvement initiatives across quality systems, processes and site operations.
• Review and approve quality documentation, including SOPs, quality agreements, validation documentation and GMP records.
• Ensure robust deviation, CAPA, change control and complaint management processes are maintained and effective.
• Manage supplier qualification programmes, audit schedules and quality oversight of third-party partners.
• Provide leadership for validation activities, including process, equipment and computerised systems validation.
• Monitor quality metrics and KPIs, identifying trends and implementing improvements where required.
• Support the maintenance of manufacturing licences and regulatory commitments.
• Collaborate closely with operational teams to ensure compliance is embedded throughout the business.
• Lead, coach and develop Quality teams, fostering a high-performance and quality-focused culture.
• Manage departmental resource planning, succession planning and team development activities.
• Ensure ongoing awareness and implementation of emerging regulatory requirements and industry best practices.

Requirements:

• Degree in a scientific discipline, ideally Pharmaceutical Science, Chemistry or a related field.
• Head of Quality experience within the pharmaceutical (parallel import) industry, alongside validation experience is highly advantageous.
• Significant experience within pharmaceutical Quality Assurance, Quality Control and Quality Systems.
• Strong knowledge of GMP regulations and pharmaceutical quality standards.
• Experience leading regulatory inspections and customer audits.
• Demonstrated leadership experience with responsibility for managing and developing teams.
• Strong understanding of Quality Management Systems, deviation management, CAPA and validation activities.
• Excellent communication, stakeholder management and influencing skills.
• Proven ability to drive continuous improvement and quality culture initiatives.
• Strong organisational, decision-making and problem-solving capabilities.
• Proficiency in quality reporting, performance metrics and compliance management.

To apply, please contact Rezaune Koopman at .