Job Description
Location United Kingdom
Sector Clinical Research & Quality Operations
Position Type Full-Time
Ignite Innovation. Champion Patient Safety. Elevate Clinical Quality.
At our organization, we are a global healthcare leader driven by an inspiring purpose to discover, develop, and deliver life-saving medicines, vaccines, and animal health products. The difference between potential and achievement lies in the spark that fuels inventiveness—a legacy we have built across more than 125 years of ethical, forward-thinking science.
We believe that world-class clinical research begins with uncompromised quality. We are seeking an experienced, proactive Country Clinical Quality Manager (CCQM) to lead clinical quality management for Clinical Trials Operations across the United Kingdom.
If you are a clinical research professional passionate about setting gold standards in Good Clinical Practice (GCP), continuous improvement, and the future of digitalized quality oversight, this is your opportunity to shape patient outcomes on a national and global scale.
The Opportunity What You’ll Do
As our Country Clinical Quality Manager, you will serve as the strategic quality guardian and local subject‑matter expert for our organization’s sponsored clinical trials in the UK. Reporting collaboratively within our regional and country leadership networks, your mission will be to safeguard patient safety, guarantee uncompromised data integrity, and drive sustainable operational excellence.
Key Responsibilities
- Regulatory & Process Leadership Act as the local authority on ICH‑GCP and evolving UK clinical trial regulations. Partner closely with Country Operations Management to maintain robust SOPs, evaluate regulatory impacts, and identify opportunities for continuous process refinement.
- Continuous Quality Improvement Lead country-level quality initiatives and collaborate on regional and global enhancement projects, turning proactive insights into standard best practices.
- Audit & Inspection Readiness Serve as the primary local point of contact for internal quality assurance bodies and health regulatory agencies (e.g., MHRA). Lead inspection preparations, conduct root‑cause analyses on findings, and drive meaningful, sustainable CAPA plans.
- Proactive Quality Control & Site Oversight Coordinate and execute comprehensive in‑house quality control plans and Quality Control Visits (QCVs). Identify trends early, conduct ad‑hoc site evaluations, and deliver targeted corrective strategies.
- Issue Escalation & Investigations Lead the escalation and investigation of significant quality, compliance, and privacy issues—including fact‑finding, root‑cause analysis, and serious breach evaluations. Oversee investigations into clinical supply GCP inquiries.
- Talent Development & Capability Building Partner with our Learning & Development functions to assess local training needs, bridge operational knowledge gaps, and coach cross‑functional study teams.
- Vendor & Supplier Qualification Manage quality evaluations and requalifications of locally selected vendors and clinical suppliers, ensuring our high quality management system (QMS) standards are upheld.
What You Bring
We are looking for an analytical, collaborative quality champion who thrives in an agile, cross‑functional clinical trials environment.
Education & Experience
- Educational Background Bachelor’s degree (or equivalent) in a relevant life sciences or healthcare discipline.
- Clinical Research Experience 6–8+ years of dedicated clinical research experience, including direct field monitoring or monitoring oversight, with a track record of operational achievement. Experience within UK Country Operations is highly preferred.
- Regulatory Expertise In-depth knowledge of ICH‑GCP guidelines, local UK statutory requirements, and end‑to‑end clinical trial workflows.
- Quality & Audit Acumen Direct experience in Clinical Quality Management, Quality Control visits/reviews, process improvement, and managing audits/regulatory inspections.
- Digital & AI‑Forward Mindset Proven ability or strong interest in leveraging modern digital assistants, analytics, or AI‑powered workflow tools to enhance trend analysis, oversight, and knowledge management.
- Leadership & Influence Demonstrated success leading cross‑functional teams, managing complex projects, and influencing stakeholders across local and international matrices.
Core Strengths
- Exceptional written and verbal communication skills with the diplomacy to navigate complex regulatory discussions.
- Strong root‑cause problem solving and objective, strategic analytical capability.
- High ethical integrity, discretion, and a collaborative, solutions‑oriented approach to conflict resolution.
Why Join Our Organization?
By joining our organization, you become an essential link in bringing groundbreaking therapies to patients who need them most. We offer
- Meaningful Impact Direct influence over the safety and integrity of cutting‑edge clinical trials.
- Growth & Empowerment Broad exposure to global clinical quality networks with continuous learning opportunities.
- Collaborative Culture An inclusive, mission‑driven environment backed by ethical leadership and supportive team members.
Ready to Make an Impact?
Take the next step in your clinical quality career. to join our team in delivering clinical research that transforms lives.
Required Skills
Clinical Quality Management, Clinical Research, Clinical Study Design, Clinical Trial Planning, Clinical Trials Monitoring, Conflict Management, Good Clinical Practice (GCP), Operational Quality, Performance Auditing, Process Improvements, Quality Control Management, Regulatory Compliance, Risk Management
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Travel Requirements
No Travel Required
Flexible Work Arrangements
Hybrid
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
N/A
Job Posting End Date
10/3/2026
- A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID
R417250
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Country Clinical Quality Manager employer: MSD in the UK
As a global healthcare leader, we offer an exceptional work environment that fosters collaboration, diversity, and professional growth. Our Medical Science Liaison role in the North of England, Scotland & Northern Ireland provides the unique opportunity to engage with healthcare professionals while contributing to improved patient outcomes. We are committed to creating a culture of respect and teamwork, ensuring our employees thrive in their careers while making a meaningful impact in the healthcare sector.
