Senior QA Manager - 12 months FTC

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

We are seeking a Senior Quality Assurance Manager to lead the deployment of site quality strategy, ensuring the highest standards of quality, compliance, and inspection readiness across manufacturing and supply operations. This role provides strategic leadership for quality systems, governance, validation activities, and continuous improvement initiatives., · 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., Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

• Significant experience in Quality Assurance within the pharmaceutical, healthcare, or highly regulated manufacturing industry.
• Strong knowledge of GMP, GDP, GCP, ISO 13485, and applicable regulatory requirements.
• Experience managing Quality Management Systems (QMS).
• Proven experience supporting audits, inspections, and compliance programmes.
• Strong leadership, stakeholder management, communication, and decision-making skills.
• Experience analysing quality data and driving process improvements.
• Degree or equivalent qualification in Pharmacy, Life Sciences, or a related scientific discipline.
• Experience leading cross-functional quality improvement projects.

Desirable

• Qualified Person (QP) status under EC/2001/83.
• Experience working within a global, matrix organisation.

At Norgine, we transform lives by delivering innovative healthcare solutions that make a meaningful difference to patients. We foster a culture of collaboration, accountability, continuous improvement, and inclusion, empowering our people to grow through a rewarding 1D career focused on personal development, achievement, and purpose.

At Norgine, you'll be part of an organisation where quality, integrity, collaboration, and continuous improvement are at the heart of everything we do. We offer opportunities to grow, develop, and make a genuine impact on patients' lives while working alongside talented colleagues across an international business.