Quality Specialist
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (33.0%).
Occupation Type
Quality assurance and regulatory professionals
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£48,200
(£24.72 per hour)
Occupation rate applies
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Description
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:
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
- 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)
- 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