Quality Officer

About Clinigen

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.

About the Role

Are you passionate about quality, compliance and continuous improvement? We are seeking a proactive and detail-oriented Quality Officer to support our Quality and Warehouse teams in maintaining the highest standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

This role is instrumental in ensuring the effective operation of our Quality Management System (QMS), safeguarding product quality and patient safety, and supporting a culture of compliance across the organisation. Working closely with cross-functional teams to provide both technical and administrative quality support while helping to communicate and embed quality standards throughout the business.

Key Responsibilities

• Maintain GMP and GDP Compliance - Support the Quality team in ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and internal quality standards.
• Support the Quality Management System (QMS) - Manage and maintain QMS records, including change controls, non-conformances, CAPAs, risk assessments and quality documentation.
• Coordinate Audits and Quality Activities - Support the client audit programme, including audit scheduling, coordination, tracking observations and assisting with responses and corrective actions.
• Drive Continuous Improvement - Produce quality reports, analyse trends and data, identify improvement opportunities, and support the implementation of process enhancements across the business.
• Investigate Quality Issues and Complaints - Work with internal teams, customers and suppliers to investigate quality concerns, identify root causes, and implement effective corrective and preventive actions.
• Manage Quality Documentation and Training - Assist with the creation, review and approval of SOPs, work instructions and quality forms, while supporting the delivery of QMS-related training to employees.
• Collaborate with Stakeholders and Support Projects - Build effective relationships with suppliers, customers, clients and internal stakeholders, contributing to business projects and providing ongoing support to the wider Quality team.