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About the Role
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.
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)
- 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
- 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
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 15 pounds at times
Skills
- Good Clinical Practice (GCP) – every 3 years
Location
- Remote
Work Type
- Full-Time
- Remote
- Up to 25 % Travel
Experience Level
- 5-7 years Quality Assurance experience in pharmaceuticals, CRO, and/or site network
- 5-7 years of Management experience
Education Level
- Bachelor and/or Master’s degree in a scientific or healthcare-related field
Benefits
- Competitive compensation
- Comprehensive benefits
- Opportunities for professional growth
About the Company
- 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.