Remote Senior QA Lead – Clinical & Biometric Systems

EDETEK Inc.; México; Remote; MXN 700,000 - 1,000,000; Full time

Job summary

EDETEK Inc. is seeking a senior QA specialist to drive quality and regulatory compliance across biometric services and computer systems. You will lead audits, risk management, and collaborate with data management, biostatistics, software validation, IT and security to ensure adherence to GxP and 21 CFR Part 11.

You will review documentation, support system validation, and drive continuous process improvements while mentoring junior QA staff in a remote setting open to South American candidates.

Qualifications

• Minimum 5 years of QA experience in clinical research, clinical systems, or regulated software environments.
• Strong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC.
• Excellent documentation and communication skills.
• Ability to communicate effectively in English (spoken and written).
• Experience conducting audits and managing CAPAs.

Responsibilities

• Document & Process Auditing: conduct host internal and vendor audits, review TMF for compliance, report findings and CAPAs.
• QMS Maintenance: develop/review policies, SOPs and ensure regulatory alignment and document control.
• Training Management: establish training curricula and monitor progress.
• Computer System Validation Support: participate in validation planning, review requirements, test scripts and validation reports.
• Audit and Inspection Readiness: plan/execute audits, ensure systems are validated and audit-ready.
• Cross-Functional Support: QA liaison across Biometrics, Software Dev, IT/Security; mentor juniors; risk assessments.

Skills

Audits & CAPA management

GxP & regulatory knowledge

QA for clinical/regulatory software

Cross-functional collaboration

Documentation & training

English communication

Education

Bachelor’s degree in life sciences / related field

Job description

EDETEK Inc. is seeking a senior QA specialist to drive quality and regulatory compliance across biometric services and computer systems. You will lead audits, risk management, and collaborate with data management, biostatistics, software validation, IT and security to ensure adherence to GxP and 21 CFR Part 11.

You will review documentation, support system validation, and drive continuous process improvements while mentoring junior QA staff in a remote setting open to South American candidates.