At a Glance
- Tasks: Lead clinical quality management for groundbreaking clinical trials across the UK.
- Company: Join MSD, a global healthcare leader committed to innovation and inclusivity.
- Benefits: Make a meaningful impact while enjoying growth opportunities and a collaborative culture.
- Other info: Be part of a mission-driven team that transforms lives through ethical leadership.
- Why this job: Shape patient outcomes and elevate clinical quality on a national and global scale.
- Qualifications: 6-8+ years in clinical research with strong knowledge of GCP and regulatory standards.
The predicted salary is between 40500 - 49500 £ per year.
This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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. 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. 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.
- 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. Apply today to join our team in delivering clinical research that transforms lives.
Country Clinical Quality Manager employer: MSD
MSD is an exceptional employer that champions inclusivity and diversity, making it a great place for individuals looking to thrive in a supportive environment. With a strong focus on employee growth and development, particularly in the dynamic field of animal health, team members benefit from collaborative partnerships and innovative sales strategies tailored to the unique needs of farmers in Wales. The company fosters a culture of high performance while ensuring that employees feel valued and empowered to make a meaningful impact in their roles.
