Clinical Research - Head of Quality Assurance

Head of Quality Assurance (Full-Time/Exempt/Remote) The Head of Quality Assurance is responsible for ensuring compliance with SOPs, OSHA, HIPAA, and study protocols. Communication with the investigator(s), team members, CRO, and sponsor is vital. About Tekton Research: Tekton Research is a growth-oriented clinical research organization committed to conducting high-quality clinical trials that advance medical knowledge and improve patient care. We are a collaborative, values-driven team that believes in Focus, Discipline, and Accountability. At Tekton Research, we take pride in doing excellent work while fulfilling our mission of Making Life Better. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a supportive and fast-paced research environment. Reports to: COO Job Description: Review/Revise and manage company SOPs, processes, and policies annuallyIdentify gaps in processes and implement accordinglyLiaise with Corporate Operations on employee training requirements and documentationCreate, maintain and enforce Quality Assurance Plans for all departments within CompanyLead and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvementsManage the scheduling, performance, reporting, and follow up of Internal QA AuditsLead and support sites during regulatory agency inspections and inquiries Develop and provide regular reporting to leadership on QA metrics Assess QA growth and development needs based on company goalsProvide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policiesResponsible for documentation, reporting, and closure of significant compliance issuesManage QA staff in accordance with company policies (plan, assign, and direct work, perform evaluations and guide professional development)Good Clinical Practice (GCP) – every 3 yearsMaintain medical license(s), certifications, etc. as applicableMaintain current with industry trends, standards, and policies. (FDA, GCP, EU, etc.)Other duties as assigned Required Skills/Abilities: Demonstrated experience scheduling, planning and hosting regulatory inspections as well as internal/external auditsQA leadership experience in highly regulated environmentsExperience developing teams and departments within medium-large organizationsComprehensive, current knowledge of clinical research requirements, processes and best practices Education and Experience: Bachelor and/or Master’s degree in a scientific or healthcare-related field5-7 years Quality Assurance experience in pharmaceuticals, CRO, and/or site network5-7 years of Management experience Physical Requirements: Prolonged periods of sitting at a desk and working on a computerMust be able to lift up to 15 pounds at times Up to 25 % Travel