Country Clinical Quality Manager

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Supervise all Clinical Quality Management activities within the designated country/cluster.

• Execute local and global processes and procedures.

• Recognize opportunities for process enhancement and assist in ongoing improvement initiatives.

• Facilitate audits, inspections, Quality Control activities, and local training programs.

• Serve as the local authority on ICH-GCP and local regulations, including evaluating the impacts of new or revised regulations.

• Manage the local network of process owners and Subject Matter Experts.

• Ensure timely updates of local SOPs and Work Instructions.

• Direct country-level continuous quality improvement efforts and support global/regional initiatives.

• Organize local training requirements and assist in local training execution.

• Oversee Quality Control activities, including IHQCP, QCVs, and QC checks.

• Conduct QC activities and perform ad hoc site visits as needed.

• Identify trends, execute root-cause analyses, and formulate local action plans.

• Act as the primary local liaison for Quality Assurance and regulatory bodies.

• Manage the preparation for audits and inspections, ongoing activities, and follow-up actions.

• Monitor CAPAs and coordinate responses to audit and inspection findings.

• Raise issues related to quality, compliance, privacy, and serious breaches and assist in investigations.

• Assess and coordinate investigations concerning clinical supply GCP inquiries and incorrect clinical supply management.

• Lead local supplier qualifications and re-qualifications and assist in resolving supplier quality issues.

• Support Quality Management System evaluations for suppliers.

• Promote local compliance and privacy initiatives and reporting.

• Contribute to global and regional key initiatives and projects.

⛳️ Requirements

• Bachelor’s Degree or equivalent in a relevant healthcare field.

• Over 6 years of pertinent experience in clinical research, including direct field monitoring experience or management/oversight of such personnel.

• Preferred experience in Country Operations.

• Comprehensive understanding of clinical trial processes, Good Clinical Practice (GCP), and other clinical research regulations.

• Proven track record in initiating, planning, and delivering projects.

• Familiarity with project management methodologies.

• Experience in leading cross-functional teams.

• Clinical Quality Management experience, ideally encompassing Quality Control Activities, Process Management, and Improvement.

• Ideally experienced in managing audits and inspections.

• Experience in coordinating and conducting training sessions is preferred.

• Exceptional oral and written communication and leadership capabilities.

• Excellent project management, organizational, and prioritization skills.

• Strong teamwork and conflict resolution abilities.

• Capacity to analyze, interpret, and resolve complex issues.

• Strategic, objective, creative, and innovative thinker.

• Ability to interact with all levels of clinical research management and influence outcomes.

• Expertise in ICH-GCP and local regulations.

• No visa sponsorship is available.

• Open to US and Puerto Rico residents only.

🏝️ Benefits

• Annual bonus.

• Long-term incentives, if applicable.

• Healthcare coverage including medical, dental, and vision.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick leave.

• Flexible remote work arrangements.