Senior QA Specialist

About the role

We are looking for a Senior QA Specialist to lead quality and compliance initiatives for our biometric services and computer systems. The role combines hands‑on QA execution with audit leadership, risk management, and close collaboration across data management, software development, IT, and security teams.

Key responsibilities

• Plan, conduct, and host internal and vendor audits; review Trial Master Files for completeness and regulatory compliance.
• Track audit findings, deviations, and CAPAs; perform risk‑based audit planning and inspection readiness assessments.
• Develop, review, and maintain SOPs, policies, and QMS documents to ensure alignment with GxP, ICH‑GCP, 21 CFR Part 11 and internal quality standards.
• Manage training curricula with functional managers, monitor overdue training and ensure completion.
• Support computer system validation activities, including review of validation plans, requirements, test scripts, IQ/OQ/PQ protocols, and change requests.
• Ensure systems meet 21 CFR Part 11 requirements such as audit trails, access control, and electronic signatures.
• Coordinate audit‑readiness activities with IT and product teams, including system validation, log monitoring, and security scans.

Required profile

• Extensive experience in quality assurance within regulated environments (GxP, ICH‑GCP, 21 CFR Part 11).
• Proven track record of leading audits, managing CAPAs, and conducting risk‑based assessments.
• Strong ability to work cross‑functionally with data management, biostatistics, software development, IT, and security teams.
• Excellent documentation and communication skills for maintaining QMS artifacts and training materials.

Required skills

• Regulatory compliance (GxP, ICH‑GCP, 21 CFR Part 11)
• Audit planning and execution
• Computer system validation (IQ/OQ/PQ)
• CAPA management
• Quality Management System documentation