Senior Manager of Quality Assurance-Clinical Site Trial Network at Johnson County Clintrials

Job DescriptionJob DescriptionDescription:Position: Senior Manager of Quality Assurance (QA)-Clinical Site Trial NetworkLocation: Multi Site/Remote with TravelDepartment: Quality DepartmentPurpose:The Senior Manager of Quality Assurance (QA) ensures the integrity, compliance, and excellence of clinical trial operations across a multi-site research network. This role provides strategic leadership in developing and maintaining a robust Quality Management System (QMS) that safeguards subject safety, ensures regulatory adherence, and promotes data reliability. By driving continuous improvement, risk mitigation, and harmonization of practices, the Senior Manager enables the organization to deliver high-quality clinical research that meets sponsor expectations and regulatory standards.Position Summary:The Senior Manager of Quality Assurance (QA) provides strategic leadership and oversight of the Quality Management System (QMS) across a multi-site clinical research network. This role ensures that all clinical trial activities adhere to regulatory requirements (FDA, ICH-GCP, HIPAA), institutional policies, and sponsor expectations. The Senior Manager is responsible for developing and maintaining quality systems that promote operational excellence, data integrity, and subject safety. Acting as a key liaison between quality, operations, and leadership teams, this position drives continuous improvement, risk mitigation, and harmonization of practices across all sites to support high-quality, compliant clinical research.Key Responsibilities (Essential Functions):Quality System OversightDevelop, implement, and maintain the organization’s Quality Management System (QMS) to ensure compliance with GCP, FDA, and sponsor requirements.Establish and maintain policies, standard operating procedures (SOPs), and quality standards for all research sites.Monitor performance metrics, trends, and audit results to proactively identify and address areas for improvement.Auditing and ComplianceLead internal audits of clinical research sites, vendors, and systems to verify regulatory and protocol adherence.Prepare for and respond to external audits and inspections (e.g., FDA, IRB, sponsor).Manage Corrective and Preventive Action (CAPA) programs and ensure timely follow-up and documentation.Training and DevelopmentDevelop and implement training programs to promote quality and compliance awareness across the organization.Mentor and support site staff in quality improvement practices.Complete onboarding, competency assessments and ongoing education related to GCP and SOPs.Risk ManagementConduct process, system, and study-level risk assessments to identify and mitigate potential compliance and operational risks.Partners with leadership and site management to implement proactive risk-based monitoring strategies.Collaboration and LeadershipServe as the primary liaison between QA, operations, regulatory, and clinical leadership teams.Collaborate with site directors and managers to integrate quality processes into study start-up, conduct, and close-out activities.Provide regular quality reports and recommendations for executive leadership.Continuous ImprovementLead process improvement initiatives across the network to increase efficiency and data quality.Utilize metrics, root cause analysis, and trend data to drive quality enhancements.Ensure harmonization of practices across all sites to maintain consistency and compliance.Education and Experience:Education:Bachelor’s degree in life science, healthcare, or related field required.Advanced degree preferred.Experience:5-7 years of experience in clinical research quality assurance or regulatory compliance, including leadership experience.Strong understanding of ICH-GCP, FDA, and other applicable regulatory requirements.Experience managing multi-site networks or large clinical research organizations preferred.Proven track record in audit management, inspection readiness, and CAPA oversight.Skills and Key Competencies:Exceptional leadership, communication, and interpersonal skills.Strong analytical, problem-solving, and organizational abilities.Ability to work collaboratively across departments and with external partners.Proficiency in quality management tools and electronic systems (e.g., eQMS, CTMS).Strategic Leadership and VisionRegulatory and Compliance ExpertiseQuality and Process ImprovementOther Requirements:Ability to travel to network sites as needed (up to 25%).Commitment to maintaining the highest ethical and professional standards in clinical research.Physical Requirements:Ability to sit for extended periods while working at a computer.Frequent use of hands and fingers for typing, writing, and handling documents.Occasional standing, walking, and bending during site visits or audits.Ability to lift and carry up to 20 lbs (e.g., audit materials, laptop, documents).Visual acuity to review detailed documents, electronic systems, and data.Ability to travel by air or ground transportation up to 25% of the time.Why JCCT?JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!EEOJCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Requirements: