AVP Laboratory Affairs (Genetics)

TL;DR

AVP Laboratory Affairs (Genetics): Leading laboratory governance, regulatory compliance, and operational performance in a high-complexity environment with an accent on accreditation readiness and quality systems. Focus on driving risk mitigation, implementing operational improvements, and ensuring inspection-ready laboratory workflows.

Location: Onsite in Houston, TX, USA

Company

hirify.global is a clinical laboratory providing advanced genetic testing and diagnostic services.

What you will do

• Lead laboratory affairs strategy, governance structures, and policy standards.
• Oversee regulatory compliance and accreditation readiness for CAP, CLIA, and FDA standards.
• Monitor laboratory KPIs and provide actionable insights to leadership.
• Drive risk mitigation through NCE evaluation, root cause analysis, and CAPA development.
• Implement operational improvements across laboratory workflows and documentation practices.
• Partner cross-functionally with medical, quality, and executive stakeholders.

Requirements

• Bachelor’s degree in a scientific discipline.
• 10+ years of experience in clinical laboratory, quality, or regulatory roles.
• 5+ years of experience in molecular diagnostics, including NGS.
• Deep expertise with CLIA, CAP, NYSDOH, OSHA, or FDA-regulated environments.
• Proven track record managing audits, inspections, and quality systems.
• Must be able to work onsite in Houston, TX.

Nice to have

• Advanced degree (Master’s, PhD, or MBA).
• Professional certification such as ASCP, CQA, RAC, or Lean Six Sigma.
• Experience in genetics or genomics environments.

Culture & Benefits

• Commitment to an inclusive and diverse workplace.
• Opportunity to lead strategic initiatives in a high-complexity clinical environment.
• Focus on continuous improvement and operational excellence.