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.

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.

Requirements

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.

Key Requirements:

• Degree in Life Sciences, Pharmacy, Pharmacology, Chemistry or a related scientific discipline preferred.
• Experience in a Quality Assurance or similar role within a regulated environment.
• Good working knowledge of GMP and GDP requirements and quality systems.
• Understanding of WDA(H), MS and MIA(IMP) licence requirements.
• Strong communication skills with the ability to work effectively with stakeholders at all levels.
• Excellent organisational, administrative and IT skills, with the ability to manage changing priorities and meet deadlines.
• Proactive, solutions-focused approach with strong attention to detail, accountability and the ability to work independently and as part of a team.

Benefits

• 27 days holiday plus 8 bank holidays
• Pension contributions 4.5% matched
• Life assurance 4 x annual salary
• Flexible Benefits Platform with £25/month Company contribution
• Annual salary review
• Independent financial advice service
• Enhanced Employee Assistance Programme
• Shopping discounts with retailers
• Long service awards
• Recognition scheme & employee of the year awards

Interested? We would love to hear from you, please apply today for consideration.