Clinical Quality Manager

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.

• 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.

• 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 with in 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.

• 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.

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

• Employee Status:
  Regular
• Relocation:
  No
• Visa Sponsorship:
  No
• Travel Requirements:
  No
• Flexible Work Arrangements:
  Hybrid
• Shift: Not Indicated
• Valid Driving License:
  No
• Hazardous Material(s): N/A
• Job Posting End Date: 10/3/2026

• 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 Preferred Skills