Head of Quality Assurance - Clinical 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.

Responsibilities

• Review/Revise and manage company SOPs, processes, and policies annually
• Identify gaps in processes and implement accordingly
• Liaise with Corporate Operations on employee training requirements and documentation
• Create, maintain and enforce Quality Assurance Plans for all departments within Company
• Lead and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements
• Manage the scheduling, performance, reporting, and follow up of Internal QA Audits
• Lead 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 goals
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Responsible for documentation, reporting, and closure of significant compliance issues
• Manage QA staff in accordance with company policies (plan, assign, and direct work, perform evaluations and guide professional development)
• Good Clinical Practice (GCP) – every 3 years
• Maintain medical license(s), certifications, etc. as applicable
• Maintain current with industry trends, standards, and policies. (FDA, GCP, EU, etc.)
• Other duties as assigned

Requirements

• Bachelor and/or Master’s degree in a scientific or healthcare-related field
• 5-7 years Quality Assurance experience in pharmaceuticals, CRO, and/or site network
• 5-7 years of Management experience
• Physical Requirements: Prolonged periods of sitting at a desk and working on a computer; Must be able to lift up to 15 pounds at times; Up to 25% Travel

Skills

• Demonstrated experience scheduling, planning and hosting regulatory inspections as well as internal/external audits
• QA leadership experience in highly regulated environments
• Experience developing teams and departments within medium-large organizations
• Comprehensive, current knowledge of clinical research requirements, processes and best practices

Benefits

We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a supportive and fast-paced research environment.