Senior QA Manager - 12 months FTC

Norgine; Hengoed; Vor Ort; GBP 70.000 - 90.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Assurance

GMP/GDP/GCP

QMS

Audits & Compliance

Leadership

Data analysis

Ausbildung

Pharmacy degree

Life Sciences degree

Jobbeschreibung

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 3D career focused on personal development, achievement, and purpose.

The Role

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.

This is a 12-month fixed-term contract (FTC) role

Key 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 & Experience

Essential

• 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.

Desirable

• Qualified Person (QP) status under EC/2001/83.
• Experience working within a global, matrix organisation.
• Experience leading cross-functional quality improvement projects.

Why Join Norgine?

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.

This job advert is a summary of the typical functions of the role and is not exhaustive. Norgine reserves the right to adapt responsibilities in line with business needs. We are committed to building an inclusive workplace where everyone can thrive and welcome applications from all backgrounds.

AI Transparency Statement:

To help us create clear and engaging job adverts, we may use AI-assisted drafting based on an approved job description. Every advert is reviewed and approved by our recruitment team before publication to ensure it accurately reflects the role and our organisation.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.