Country Clinical Quality Manager - UK & Ireland

Job Description

We are a global healthcare leader with a rich legacy of 125 years, dedicated to achieving new milestones in global healthcare. We are looking for a passionate and driven Country Clinical Quality Manager to ensure the safety and integrity of our clinical trials in the UK and Ireland. If you are ready to make a difference in healthcare, we want to hear from you.

Key Responsibilities:

• Oversee all clinical quality activities in the UK and Ireland, ensuring patient safety, high-quality data, and compliance with regulations for sponsored clinical trials
• Implement and improve local/global processes and procedures, identifying opportunities for process enhancement and leading continuous improvement initiatives
• Serve as the local expert on ICH-GCP, local regulations, and quality-related processes
• Manage the local network of owners/Subject Matter Experts (SMEs) for global/local processes, ensuring proper implementation and regular updates of local Standard Operating Procedures (SOPs) and Work Instructions (WIs)

Quality Control and Training:

• Coordinate and oversee all Quality Control (QC) activities, including the execution of the In-house Quality Control Plan, Quality Control Visits, and other QC checks
• Identify and address local trends, perform root-cause analysis, and develop local action plans to drive quality improvements
• Serve as the local training point of contact and liaison between local country operations and Learning & Development (L&D), identifying and coordinating local training needs

Audits, Inspections, and Compliance:

• Act as the primary point of contact for Research Laboratories Quality Assurance and Regulatory Agencies, managing and supporting activities during the preparation, ongoing, and follow-up phases of audits or inspections
• Communicate and escalate quality/compliance issues to local country operations management, supporting investigations and reporting of "Serious Breaches" if applicable
• Evaluate trends on Clinical Supply GCP Inquiries and coordinate GCP Investigations of trends related to Clinical Supply GCP Inquiries

Education and Experience Requirements:

• Bachelor's Degree or equivalent in a relevant healthcare area
• Extensive relevant experience in clinical research, including direct field monitoring experience or management/oversight of such individuals
• Solid track record of initiating, planning, and delivering projects, along with experience in managing audits, inspections, and coordinating training sessions

If you possess superior communication and people management skills, excellent project management and organizational skills, and a passion for driving quality and innovation in healthcare, we invite you to apply for this exciting opportunity.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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