Senior QA Leader — Quality Systems & Compliance

Norgine B.V.; Cefn Hengoed; On-site; GBP 90,000 - 130,000; Full time

Job summary

Norgine B.V. seeks a Senior Quality Assurance Manager to lead deployment of site quality strategy across manufacturing and supply operations, ensuring top quality, compliance, and inspection readiness.

You will steer quality systems, governance, validation activities, and continuous improvement, partnering with global stakeholders. The role requires significant QA experience in pharmaceutical manufacturing, deep GMP/GDP/GCP and ISO knowledge, QMS leadership, audits, CAPAs, and change controls.

Qualifications

• Significant experience in Quality Assurance within the pharmaceutical manufacturing industry.
• Strong knowledge of GMP, GDP, GCP, ISO 13485, and applicable regulatory requirements.
• Experience managing Quality Management Systems (QMS).
• Experience leading audits, inspections, and compliance programmes.
• Degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Experience leading cross-functional quality improvement projects.

Responsibilities

• Lead deployment of site quality strategy across manufacturing and supply operations.
• Develop quality systems, governance, and compliance programs.
• Ensure GMP, GDP, GCP, ISO standards and regulatory compliance.
• Drive inspection readiness and support regulatory inspections and audits.
• Oversee investigations, deviations, CAPAs, change controls, and validation activities.
• Provide guidance on QMS and regulatory compliance.
• Monitor quality performance metrics and drive continuous improvement.
• Foster relationships with internal and external stakeholders to support objectives.
• Contribute to One Norgine Quality model and global standards.

Skills

Quality Assurance

GMP/GDP/GCP

QMS

Audits & inspections

Leadership

Regulatory compliance

Data analysis

CAPA management

Change control

Education

Degree in Pharmacy or Life Sciences

Job description

Norgine B.V. seeks a Senior Quality Assurance Manager to lead deployment of site quality strategy across manufacturing and supply operations, ensuring top quality, compliance, and inspection readiness.

You will steer quality systems, governance, validation activities, and continuous improvement, partnering with global stakeholders. The role requires significant QA experience in pharmaceutical manufacturing, deep GMP/GDP/GCP and ISO knowledge, QMS leadership, audits, CAPAs, and change controls.