Country Clinical Quality Manager
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Job Description
Clinical Quality Manager overseeing quality, compliance, audits, and GCP processes for Merck’s US clinical trials. Coordinating QC, investigations, training, suppliers, and regulatory responses.
Responsibilities:
- Oversee all Clinical Quality Management activities in the respective country/cluster
- Implement local and global processes and procedures
- Identify process improvement opportunities and support continuous improvement initiatives
- Support audits, inspections, Quality Control activities, and local training
- Act as local expert for ICH-GCP and local regulations, including assessing impacts of new or updated regulations
- Manage the local network of process owners and Subject Matter Experts
- Ensure regular updates of local SOPs and Work Instructions
- Lead country-level continuous quality improvement activities and support global/regional initiatives
- Coordinate local training needs and support local training delivery
- Coordinate and oversee Quality Control activities, including IHQCP, QCVs, and QC checks
- Perform QC activities and ad hoc site visits when requested
- Identify trends, conduct root-cause analyses, and develop local action plans
- Serve as primary local contact for Quality Assurance and regulatory agencies
- Manage audit and inspection preparation, ongoing activities, and follow-up
- Track CAPAs and coordinate responses to audit and inspection reports
- Escalate quality, compliance, privacy, and serious breach issues and support investigations
- Evaluate and coordinate investigations related to clinical supply GCP inquiries and incorrect clinical supply management
- Lead local supplier qualifications and re-qualifications and support supplier quality issue resolution
- Support Quality Management System assessments for suppliers
- Support local compliance and privacy initiatives and reporting
- Support global and regional key initiatives and projects
Requirements:
- Bachelor's Degree or equivalent in relevant health care area
- 6+ years of relevant experience in clinical research, including direct field monitoring experience or management/oversight of such individuals
- Experience in Country Operations preferred
- Deep knowledge of clinical trial processes, Good Clinical Practice (GCP), and other clinical research regulations
- Track record of initiating, planning, and delivering projects
- Knowledge of project management practices
- Experience leading cross-functional teams
- Clinical Quality Management experience ideally including Quality Control Activities, Process Management & Improvement
- Experience managing audits and inspections ideally
- Experience coordinating and delivering training sessions ideally
- Superior oral and written communication and leadership skills
- Excellent project management, organizational, and prioritization skills
- Excellent teamwork and conflict resolution skills
- Ability to analyze, interpret, and solve complex problems
- Strategic, objective, creative, and innovative thinking
- Ability to interact with all levels of clinical research management and exert influence to achieve results
- Expertise in ICH-GCP and local regulations
- No visa sponsorship available
- US and Puerto Rico residents only
Benefits:
- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Remote work arrangement
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