Head of Quality Assurance, Clinical Research

🔥 3 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Tekton Research

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 Private equity on 2023-10

Healthcare • Consulting • Logistics

Tekton Research is a multi-site clinical research organization headquartered in Austin, TX that conducts Phase 1–4 clinical trials across neuroscience, cardiometabolic, infectious disease, and general medicine. The company partners with sponsors, CROs, and biopharma to develop drugs, medical devices, and diagnostics, operating a network of physician-led research sites across multiple U. S. states with rapid site activation, dedicated patient recruitment capabilities, and high participant retention. Tekton emphasizes patient-centered care while delivering operational scale for complex and high-volume trials.

📋 Description

• Review, revise, and manage company SOPs, processes, and policies annually • Identify process gaps and implement improvements • Liaise with Corporate Operations on employee training requirements and documentation • Create, maintain, and enforce Quality Assurance Plans for all company departments • Lead and/or participate in critical projects supporting 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 QA metrics reporting to leadership • Assess QA growth and development needs based on company goals • Provide guidance, interpretation, support, training, and input to development groups regarding regulations, guidelines, corporate standards, and policies • Manage documentation, reporting, and closure of significant compliance issues • Manage QA staff, including planning, assigning, and directing work, conducting evaluations, and guiding professional development • Maintain current knowledge of industry trends, standards, and policies, including FDA, GCP, and EU requirements • Perform other duties as assigned • Report to the COO

🎯 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 • 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 • Good Clinical Practice (GCP) certification/training every 3 years • Maintain medical license(s), certifications, etc. as applicable • Ability to travel up to 25% • Able to sit for prolonged periods and work on a computer • Must be able to lift up to 15 pounds at times

🏖️ Benefits

• Competitive compensation • Comprehensive benefits • Opportunities for professional growth • Supportive and fast-paced research environment