Quality Director – GMP & Regulatory Excellence

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

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.