Clinical Research - Head of Quality Assurance

Tekton Research Inc•Austin, TX

4d•Remote

About The Position

The Head of Quality Assurance ensures compliance with SOPs, OSHA, HIPAA, and study protocols. The role requires communication with investigators, team members, CROs, and sponsors. The position manages company quality systems, leads audits and inspection support, advises on regulatory requirements, reports on QA metrics, and oversees QA staff and their professional development. It is a full-time, exempt, remote position with up to 25% travel. The role reports to the COO. Tekton Research is a growth-oriented clinical research organization conducting clinical trials to advance medical knowledge and improve patient care. The company describes itself as collaborative and values-driven, with a focus on Focus, Discipline, and Accountability. It offers competitive compensation, comprehensive benefits, and professional growth opportunities in a supportive, fast-paced research environment.

Requirements

Demonstrated experience scheduling, planning, and hosting regulatory inspections and internal or external audits.
QA leadership experience in highly regulated environments.
Experience developing teams and departments within medium-to-large organizations.
Comprehensive, current knowledge of clinical research requirements, processes, and best practices.
Bachelor's and/or master's degree in a scientific or healthcare-related field.
5–7 years of Quality Assurance experience in pharmaceuticals, a CRO, and/or a site network.
5–7 years of management experience.

Responsibilities

Review, revise, and manage company SOPs, processes, and policies annually.
Identify process gaps and implement improvements.
Coordinate with Corporate Operations on employee training requirements and documentation.
Create, maintain, and enforce Quality Assurance Plans for all company departments.
Lead or participate in assessing, developing, and implementing projects that support continuous quality improvement.
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 QA metrics reports to leadership.
Assess QA growth and development needs in relation to company goals.
Provide guidance, interpretation, support, training, and input to development groups on regulations, guidelines, corporate standards, and policies.
Document, report, and close significant compliance issues.
Manage QA staff by planning, assigning, and directing work, conducting evaluations, and guiding professional development.
Complete Good Clinical Practice (GCP) training every three years.
Maintain applicable medical licenses and certifications.
Stay current with industry trends, standards, and policies, including FDA, GCP, and EU requirements.
Perform other duties as assigned.