The Quality Specialist supports the Pharmaceutical Quality System, ensures compliance with GxP standards, manages documentation, oversees CMOs, and supports audits while driving continuous improvement.
Who We Are:
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa.
The Role:
As a Quality Specialist within the Commercial Products Quality Assurance team, you will support the ongoing maintenance and operation of the Pharmaceutical Quality System (PQS). You will coordinate quality-related tasks and activities across internal teams and external partners, ensuring robust oversight of Clinigen Marketing Authorisation Holder (MAH) responsibilities. This role has a strong focus on maintaining GxP standards, regulatory compliance, and high-quality processes to ensure the safe and effective management of commercial products.
Key Responsibilities:
- Maintain and comply with Quality System requirements, including following and enforcing SOPs, job aids, company policies and GxP/GMP standards.
- Manage core Quality Management System processes for Commercial Products, such as change controls, non‑conformances, quality complaints, and related documentation.
- Create, review and approve quality documentation, including SOPs, work instructions, forms, technical reports, and quality records (electronic and paper).
- Act as a Subject Matter Expert (SME) by supporting batch review and release, Annual Product Quality Reviews, Quality Technical Agreements, and investigations with internal and external stakeholders.
- Liaise with and oversee Contract Manufacturing Organisations (CMOs) through documentation review, meetings, stability programme coordination, and issue resolution.
- Support audits and inspections, including internal audits, external audits, and client or competent authority inspections.
- Contribute to continuous improvement and business projects, including providing training, influencing decisions, problem‑solving, and completing additional duties to support ongoing operations.
Requirements
- Life Science (or allied discipline) degree or equivalent experience/education
- Experience of working within the pharmaceutical / healthcare / life sciences industry in a Quality Assurance function
- Experience of working to the standards and requirements of Good Manufacturing Practise (GMP)
- Previous experience in the management of outsourced activities and/or the management of CMOs in a pharmaceutical setting is advantageous
- Strong organisational skills
- Strong interpersonal, collaboration and communication skills, across all seniority levels
- Able to promote GMP principles across Clinigen departments
- Excellent attention to detail
- Able to effectively multitask and prioritise a dynamic workload within defined deadlines
- Self-motivated and tenacious in pursuit of objectives
- Strong Computer Literacy (Word, Excel, PowerPoint, SharePoint, Outlook, eQMS
Benefits
- 27 days holiday plus 8 bank holidays
- Pension contributions - 4.5% matched
- Life assurance - 4x 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
Top Skills
Eqms
Excel
Outlook
PowerPoint
Sharepoint
Word
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