[Hiring] Head of Quality Assurance @Tekton Research Inc

Role Description

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.

• 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 participate 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

Qualifications

• 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

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