Director of Quality Assurance

The Director of Quality Assurance is responsible for ensuring site compliance with SOPs, OSHA, HIPAA, and study protocols. Communication with the investigators, team members, CRO and sponsor is vital.

Please note: This is a remote opportunity, but you must reside in a state that we do business in: TX, OK, GA, KS, CO, NC, VA

Job Description:

• 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 Tekton Research, Inc.
• Lead and/or participate in the assessment, development, and implementation of critical projects in support of continuous quality improvements
• Manage the scheduling and performance of Internal QA Audits
• Support sites during regulatory agency inspections and inquiries
• Provide regular reporting to CEO 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
• Oversee 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.

Essential Qualifications:

• Master or Bachelor's degree in scientific or healthcare-related field
• Demonstrated experience in scheduling, planning and hosting regulatory inspections, as well as internal/external audits
• 5 - 7 years Quality Assurance experience in pharmaceuticals, CRO, and/or site network
• 3 - 5 years Management experience
• Up to 25% Travel

https://tektonresearch.com/

Job Type: Full-time