Team Lead – Deviation & CAPA (Quality Assurance)

About the role

The Team Lead – Deviation & CAPA will head the Quality Assurance Compliance team, ensuring all operations meet cGMP, GDP, ISO and other regulatory standards. This role drives continuous improvement, oversees the Quality Management System and leads the organization through audits and inspections.

Key responsibilities

• Lead daily QA compliance activities and maintain the Quality Management System (QMS).
• Supervise review, investigation and closure of deviations, market complaints and CAPAs.
• Plan, coordinate and conduct internal audits and prepare for regulatory inspections.
• Approve audit reports and ensure timely implementation of corrective actions.
• Manage SOPs, quality manuals and controlled documents, ensuring Good Documentation Practices.
• Coach and develop the QA compliance team, delivering GMP and compliance training.
• Lead continuous‑improvement and risk‑management projects, applying data‑integrity principles (ALCOA+).
• Support environmental, health and safety initiatives in line with ISO 14001:2015.

Required profile

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Biotechnology or a related field.
• 5–10 years of QA/Compliance experience in the pharmaceutical or biotechnology industry.
• At least 2–3 years of supervisory or team‑lead experience.

Required skills

• cGMP, GDP and ISO standards knowledge.
• CAPA management and QMS oversight.
• Audit planning and execution.
• Document control and Good Documentation Practices.
• Data integrity (ALCOA+) implementation.
• Regulatory inspection preparation.