Country Clinical Quality Manager, US - Remote
About the position Responsibilities • Oversee all Clinical Quality Management activities in the respective country/cluster. • Implement local/global processes and procedures for clinical trials. • Identify opportunities for process improvement and support continuous improvement initiatives. • Support audits and inspections, ensuring compliance with regulations. • Coordinate and oversee Quality Control activities, including execution of the In-house Quality Control Plan. • Act as the primary local point of contact for Quality Assurance and Regulatory Agencies during audits and inspections. • Manage and track Corrective and Preventive Actions (CAPAs) related to audit observations. • Lead local supplier qualifications and re-qualifications, addressing quality issues as needed. • Identify and coordinate local training needs and support local training sessions. • Communicate and escalate quality/compliance issues to management. Requirements • Bachelor's Degree or equivalent in a relevant healthcare area. • Minimum of 6 years of relevant experience in clinical research, including direct field monitoring experience. • Deep knowledge of Clinical Trial processes, GCP, and related regulations. • Solid track record in project management and delivery. • Experience in leading cross-functional teams. • Experience in Clinical Quality Management, including Quality Control Activities and Process Management. Nice-to-haves • Experience in Country Operations preferred. • Experience in managing audits and inspections. • Experience in coordinating and delivering training sessions. Benefits • Bonus eligibility • Long-term incentive if applicable • Health care and other insurance benefits for employee and family • Retirement benefits • Paid holidays • Vacation • Sick days Apply tot his job