Senior QA Leader — GMP/GDP/GCP Compliance & Strategy

Norgine; Hengoed; On-site; GBP 70,000 - 90,000; Full time

Job summary

Norgine is seeking a Senior Quality Assurance Manager to lead the deployment of site quality strategy across manufacturing and supply operations. This role provides strategic leadership for quality systems, governance, validation activities, and continuous improvement.

Based in the UK, the role focuses on GMP/GDP/GCP compliance, inspection readiness, and collaboration with internal and external stakeholders to uphold high standards and support regulatory inspections.

Qualifications

• Significant experience in Quality Assurance within pharma or regulated manufacturing.
• Strong knowledge of GMP, GDP, GCP, ISO 13485 and regulatory requirements.
• Experience managing Quality Management Systems (QMS) and audits.
• Proven leadership, stakeholder management and decision-making skills.
• Degree in Pharmacy or Life Sciences or related field.

Responsibilities

• Lead and develop quality systems, compliance programmes, and quality governance activities.
• Ensure ongoing compliance with GMP, GDP, GCP, ISO standards, and regulatory requirements.
• Drive inspection readiness and support regulatory inspections, audits, and self-inspections.
• Oversee quality incident investigations, deviations, CAPAs, change controls, and validation activities.
• Provide expert guidance on quality management systems (QMS) and regulatory compliance.
• Monitor quality performance metrics and identify opportunities for continuous improvement.
• Build strong relationships with internal and external stakeholders to support business objectives.
• Contribute to the implementation of the One Norgine Quality model and global quality standards.

Skills

Quality Assurance

GMP/GDP/GCP

QMS

Audits & Compliance

Leadership

Data analysis

Education

Pharmacy degree

Life Sciences degree

Job description

Norgine is seeking a Senior Quality Assurance Manager to lead the deployment of site quality strategy across manufacturing and supply operations. This role provides strategic leadership for quality systems, governance, validation activities, and continuous improvement.

Based in the UK, the role focuses on GMP/GDP/GCP compliance, inspection readiness, and collaboration with internal and external stakeholders to uphold high standards and support regulatory inspections.