Head of Quality

Smart4 Sciences; Manchester; On-site; GBP 90,000 - 130,000; Full time

Job summary

Smart4 Sciences in Manchester seeks an experienced Head of Quality to own site-wide Quality operations, drive GMP compliance, and lead continuous improvement across QA, QC and quality systems.

You will manage a team of QA and QC staff, oversee regulatory inspections, risk management, CAPA and validation activities, and partner with operations to embed a robust quality culture across the site.

Qualifications

• Degree in a scientific discipline, ideally Pharmaceutical Science, Chemistry or a related field.
• Head of Quality experience within the pharmaceutical (parallel import) industry is highly advantageous.
• Strong knowledge of GMP regulations and pharmaceutical quality standards.
• Experience leading regulatory inspections and customer audits.

Responsibilities

• Provide strategic and operational leadership for QA and QC departments, and drive site quality strategies.
• Act as primary quality representative for regulatory authorities, customers and internal stakeholders.
• Lead regulatory inspections and customer audits, ensuring inspection readiness.
• Maintain and enhance GMP-compliant Quality Management Systems across the site.

Skills

Leadership

Quality Assurance

GMP knowledge

Regulatory inspections

Stakeholder management

Continuous improvement

Team development

Communication

Problem solving

Education

Pharmaceutical Science degree

Job description

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.