Country Quality Manager

About the role

The Country Quality Manager ensures product quality conformity with specifications and that production activities comply with Novartis quality policy and GxP requirements. This fixed‑term position is based in Prague and involves maintaining up‑to‑date documentation and staying current with GxP trends.

Key responsibilities

• Ensure handling, manufacturing, and distribution of biopharmaceutical products meet Novartis Quality Manual, Quality Agreements, GxP regulations, and local SOPs.
• Review batch documentation, archive records, and conduct self‑inspection programs.
• Manage QA investigations, corrective actions, and documentation for deviations, complaints, recalls, and stability failures.
• Escalate quality issues, support global assessments, and handle change requests from receipt to closure.
• Assess quality trends, drive continuous improvement, and develop SOPs as needed.
• Plan and monitor GxP training programs and maintain cross‑functional communication with internal teams, authorities, and global QA.

Required profile

• University degree in Pharmacy, Life Sciences, Chemistry or related field.
• Minimum 3 years of Quality Assurance experience in the pharmaceutical industry.
• Fluent Czech and/or Slovak with professional English proficiency.

Required skills

• GMP and GDP knowledge.
• Deviation management, CAPA, change control, complaints handling.
• Quality risk management and GxP monitoring.
• Experience with QA investigations and documentation archiving.
• Qualified Person (QP) activities (advantageous).

What we offer

• Annual base salary between 906,500 and 1,683,500 CZK.
• Performance‑based bonus potential.
• Hybrid working options, flexible benefits, pension matching, insurance, 5‑week holiday, meal vouchers, transport allowance, and other employee perks.