Senior Clinical Quality Manager

Walker Cole International; Greater London; On-site; GBP 90,000 - 120,000; Full time

Job summary

Walker Cole International is partnering with a London-headquartered pharmaceutical business to identify a Senior Clinical Quality Manager for their global operations. This role sits within the Global Quality function, providing quality oversight across clinical studies and partnering with cross-functional teams to ensure activities comply with GCP, regulations and internal standards.

Responsibilities include acting as the QA point of contact for studies, advising on risk-based quality oversight,

Qualifications

• Strong track record in Clinical Quality Assurance (GCP) within pharma or biotech.
• Hands-on experience with GCP-regulated clinical studies (interventional and non-interventional).
• Solid working knowledge of GCP and risk-based quality oversight; exposure to MHRA, EMA or FDA inspections.
• Confidently operate and influence within a global matrix structure.
• Master's degree or equivalent scientific background is required or strongly preferred.

Responsibilities

• Act as QA point of contact for clinical studies across therapeutic areas, aligning activities with GCP and regulatory expectations.
• Advise cross-functional study teams on quality matters and implement risk-based oversight.
• Lead investigations, CAPAs and quality planning; drive improvements across clinical quality systems.
• Prepare the business for GCP inspections and audits, and participate actively during inspections.
• Monitor vendors and clinical partners to ensure they meet quality standards.

Skills

GCP knowledge

Quality leadership

Education

Master's degree or equivalent scientific background

Job description

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 |