Remote QA Leader, Clinical Research Excellence

Socket.dev; Austin (TX); On-site; USD 150,000 - 210,000; Full time

Job summary

Tekton Research is seeking a Head of Quality Assurance to lead our QA program across SOPs, audits, and regulatory compliance. This remote, full-time role reports to the COO and requires strong leadership in regulated environments and collaboration with CROs, sponsors, and investigators.

You will oversee QA plans, internal audits, inspections, and continuous improvements, ensuring adherence to GCP, FDA/EU guidelines, and training documentation.

Qualifications

• Bachelor 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

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

Skills

QA leadership

Audits

Regulatory inspections

Team development

Education

Bachelor's or Master’s degree in a scientific or healthcare-related field

Job description

Tekton Research is seeking a Head of Quality Assurance to lead our QA program across SOPs, audits, and regulatory compliance. This remote, full-time role reports to the COO and requires strong leadership in regulated environments and collaboration with CROs, sponsors, and investigators.

You will oversee QA plans, internal audits, inspections, and continuous improvements, ensuring adherence to GCP, FDA/EU guidelines, and training documentation.