JOB SUMMARYThe AVP Laboratory Affairs is a senior laboratory leadership role responsible for advancing laboratory governance, regulatory compliance, accreditation readiness, policy oversight, quality systems, and operational performance across Baylor Genetics' high-complexity laboratory environment. This role provides enterprise-level oversight of laboratory KPIs, benchmark performance, risk identification, Non-Conforming Event (NCE) evaluation, root cause analysis (RCA), and corrective and preventive actions.
This role partners across laboratory, medical, quality, regulatory, and operational teams to identify improvement opportunities, mitigate risk, and ensure inspection-ready, reliable, and scalable laboratory operations. Success is defined by sustained regulatory readiness, strong quality performance, effective risk mitigation, and continuous improvement in support of operational excellence and patient impact. This role may evolve as organizational needs change.
KEY RESPONSIBILITIES- Lead laboratory affairs strategy, including governance structures, operating cadences, and policy standards to ensure consistent, compliant laboratory operations
- Oversee regulatory compliance and accreditation readiness (CAP, CLIA, OSHA, FDA or equivalent), including audit preparation, inspections, responses, and remediation
- Establish and monitor laboratory KPIs, including trend tracking, statistical analysis, and leadership reporting with actionable insights
- Drive risk mitigation through NCE evaluation, root cause analysis (RCA), and CAPA development and monitoring
- Identify and implement operational improvements across laboratory workflows, quality performance, throughput, and documentation practices
- Oversee laboratory policy and procedure governance, including document control, review cycles, approvals, and training compliance
- Develop and lead laboratory training and competency programs to support onboarding, inspection readiness, and quality expectations
- Partner cross-functionally with laboratory leadership, medical directors, quality, regulatory, HR, and executive stakeholders to align priorities and escalate risk
- Promote a culture of quality, accountability, and continuous improvement across laboratory teams
- Perform other duties as assigned to support organizational objectives
- Comply with all company policies, procedures, and applicable regulatory requirements
QUALIFICATIONSRequired- Bachelor's degree in a scientific discipline (e.g., Medical Laboratory Science, Biology, Chemistry, or related field)
- 10+ years of experience in clinical laboratory, quality, regulatory, or laboratory operations roles
- 5+ years of experience in molecular diagnostics, including next generation sequencing (NGS)
- Deep experience with CLIA, CAP, NYSDOH, OSHA, and/or FDA-regulated high-complexity laboratory environments
- Proven track record managing audits, inspections, compliance programs, and quality systems
- Demonstrated expertise in NCE management, RCA, CAPA processes, and KPI reporting
- Strong analytical, communication, and presentation skills
- Ability to manage multiple priorities in a fast-paced environment and influence cross-functional stakeholders
- Equivalent combination of education and experience may be considered
Preferred- Advanced degree (Master's, PhD, MBA, or equivalent)
- Professional certification (e.g., ASCP, CQA, RAC, Lean Six Sigma)
- Experience in genetics, genomics, or high-complexity molecular laboratory environments
- Experience with quality management systems, laboratory information systems, and KPI dashboards
- Experience presenting to senior leadership
COMPETENCIES- Strategic Agility
- Decision Quality
- Process Management
- Drive for Results
- Organizational Agility
PHYSICAL DEMANDS AND WORK ENVIRONMENT- Location: Onsite; requires regular presence in laboratory and office environments
- Ability to work in a high-complexity laboratory setting with appropriate PPE and safety compliance
- Exposure to laboratory chemicals and biological materials when in lab areas
- Must be able to sit, stand, and walk for extended periods as needed
- Occasional lifting up to 25 lbs
- May require occasional travel
- Flexibility to support audits, inspections, or urgent operational needs
