Quality Release Specialist

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.

We are seeking a proactive and detail-driven Quality Release Specialist to support our Quality and Warehouse teams. This role plays a key part in ensuring compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), supporting the effective operation of the Quality Management System (QMS), and safeguarding product quality and patient safety.

You will work closely with cross-functional teams, external partners, and regulators, providing both technical and administrative quality support across a wide range of activities.

Key Responsibilities:

• Manage day-to-day activities within the Quality Management System (QMS), partnering with cross-functional teams to investigate, review, and close quality records within the electronic QMS.
• Create, review, and approve quality documentation, including SOPs, work instructions, and forms, ensuring compliance with Good Documentation Practice.
• Maintain GMP and GDP standards, managing accurate paper and electronic quality records in line with company procedures and regulatory requirements.
• Investigate quality issues and customer complaints, working collaboratively to identify root causes, prioritize actions, and implement pragmatic, compliant solutions.
• Communicate quality system requirements effectively to employees, support quality-related training, and influence others to achieve quality objectives.
• Support internal, external, and regulatory audits and inspections, including preparation, participation, and completion of corrective and preventative actions (CAPAs).
• Drive continual improvement by analyzing quality data, identifying process improvement opportunities, acting as a Quality stakeholder on projects, managing key supplier relationships, escalating risks to management, and supporting the wider Quality team as needed.