Walker Cole International is partnered with a multinational pharmaceutical business headquartered in London to identify a Senior Clinical Quality Manager for their global operations.
Sitting within the Global Quality function, this role provides quality oversight and support across their clinical studies, partnering closely with several cross-functional teams to ensure all activities are conducted in compliance with GCP, regulations, and internal quality standards.
As the Senior Clinical Quality Manager, your responsibilities will include:
- Acting as the QA point of contact for clinical studies across several therapeutic areas, working closely with clinical and medical teams to keep activities aligned with GCP and regulatory expectations
- Advising cross-functional study teams on quality matters and embedding a risk-based approach to quality oversight
- Leading on investigations, CAPAs, and quality planning, while driving broader improvement initiatives across clinical quality systems
- Preparing the business for GCP inspections and audits, and playing an active role when they take place
- Keeping an oversight eye on vendors, service providers, and other clinical partners to ensure they meet the same quality bar
To be considered for this opportunity, you should possess:
- A strong track record in Clinical Quality Assurance (GCP) gained within pharma or biotech
- Hands-on experience with GCP-regulated clinical studies, spanning both interventional and non-interventional programmes
- Solid working knowledge of GCP and risk-based quality oversight, including exposure to inspections from bodies such as the MHRA, EMA, or FDA
- Confidence operating and influencing within a global matrix structure
- A Master's degree or equivalent scientific background
GCP | Good Clinical Practice | Clinical Trials | Phase I | Phase II | Phase III | Clinical Studies | Medical Affairs | Risk Assessment | MHRA | FDA | EMA |
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Senior Clinical Quality Manager employer: Walker Cole International
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