Remote Senior QA & Compliance Lead | GxP, Audits & Validation

EDETEK Inc.; Chile; Presencial; CLP 83.487.940 - 111.317.253; Jornada completa

Descripción de la vacante

EDETEK Inc. is seeking a senior QA specialist to drive compliance and quality across biometric services and computer systems.

You will execute QA activities, lead audits, and collaborate with data management, biostatistics, software development, validation, IT, and security to ensure regulatory adherence. You will review documents, manage CAPAs, validate systems, and continuously improve processes while aligning with 21 CFR Part 11 and related standards.

Formación

• Bachelor’s degree in life sciences, computer science, or related field.
• Minimum of 5 years QA experience in clinical research or regulated software environments.
• Strong knowledge of GxP, ICH‑GCP, 21 CFR Part 11, Annex 11, and SDLC.
• Proven experience conducting audits and managing CAPAs.

Responsabilidades

• Document and process auditing across QA systems and records.
• Lead internal and vendor audits and track CAPAs.
• Review TMF for completeness and regulatory compliance.
• Plan risk-based audits and ensure inspection readiness.
• Maintain QMS documents and SOPs with periodic reviews.
• Collaborate with IT, Biometric, and software teams on validation.
• Coordinate with cross-functional managers on training curricula.
• Ensure CVP, IQ/OQ/PQ, and traceability matrices are prepared.

Conocimientos

QA experience

Audits

GxP knowledge

ICH-GCP

Documentation

Cross-functional

Educación

Bachelor’s degree in life sciences

Herramientas

ZenQMS

MS Office

Descripción del empleo

EDETEK Inc. is seeking a senior QA specialist to drive compliance and quality across biometric services and computer systems.

You will execute QA activities, lead audits, and collaborate with data management, biostatistics, software development, validation, IT, and security to ensure regulatory adherence. You will review documents, manage CAPAs, validate systems, and continuously improve processes while aligning with 21 CFR Part 11 and related standards.