Head of Quality

Pharmaceutical Manufacturing & Regulatory Affairs

Hertfordshire

An exciting opportunity has arisen for an experienced Quality leader to join a growing pharmaceutical organisation as Head of Quality. This strategic leadership role will take responsibility for Quality Assurance, Quality Control, Regulatory Affairs, Product Safety, and Quality Systems, ensuring the highest standards of GMP compliance, product quality, and patient safety.

The Role

As Head of Quality, you will provide leadership across all quality and regulatory functions, driving a culture of compliance, continuous improvement, and operational excellence. You will act as a key member of the senior leadership team, supporting business objectives while ensuring regulatory requirements are consistently met.

Key Responsibilities

• Lead and continually enhance the Pharmaceutical Quality System (PQS).
• Promote a company-wide culture of quality, compliance, and patient safety.
• Act as the primary contact for regulatory authorities and external inspections.
• Lead MHRA inspections, customer audits, supplier audits, and regulatory responses.
• Oversee quality systems including deviations, CAPAs, change controls, complaints, investigations, and audit programmes.
• Drive continuous improvement initiatives through quality metrics and KPI reporting.
• Manage supplier quality programmes and product lifecycle quality activities.
• Provide strategic oversight of Quality Control laboratories, validation activities, and stability programmes.
• Support pharmacovigilance, product safety, and technical product complaint investigations.
• Lead, develop, and inspire multidisciplinary teams across Quality, Regulatory Affairs, Product Safety, and Quality Systems.

About You

We are looking for a motivated and influential quality professional with a proven track record of leading quality and regulatory functions within a pharmaceutical environment.

Essential Requirements

• Degree qualified in Pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology, or a related Life Science discipline.
• Significant leadership experience within pharmaceutical quality and regulatory compliance.
• Strong understanding of GMP, GxP, and pharmaceutical regulatory requirements.
• Experience leading regulatory inspections and audits.
• Demonstrable success in managing quality systems, validation, supplier quality, and compliance programmes.
• Proven ability to build, mentor, and develop high-performing teams.

What You'll Bring

• Strategic leadership and decision-making skills.
• Excellent communication and stakeholder management abilities.
• A collaborative and people-focused leadership style.
• Strong problem-solving and risk-management capabilities.
• A commitment to quality, integrity, compliance, and patient safety.

This is an excellent opportunity for an experienced quality leader seeking a highly visible role where they can shape quality strategy, influence organisational performance, and contribute to the delivery of safe, compliant pharmaceutical products.