NCQ Manager – GxP Quality Assurance

About the role

The NCQ Manager ensures that all biopharmaceutical and pharmaceutical products, processes and procedures comply with GxP regulations, Novartis quality policies and local specifications. The role drives continuous improvement, oversees documentation, and supports product launches while maintaining strong relationships with regulatory authorities and internal stakeholders.

Key responsibilities

• Ensure handling, manufacturing and distribution activities meet Novartis Quality Manual, GxP regulatory requirements and local SOPs.
• Prepare, review and verify batch documentation for accuracy and completeness; archive original records for the required retention period.
• Plan, conduct and monitor self‑inspection schemes and GxP monitoring across all sections.
• Investigate non‑compliance, manage corrective actions and oversee critical quality issues such as deviations, complaints, recalls, counterfeits and stability failures.
• Escalate instability incidents per Novartis policy and lead global quality assessments and change‑request management.
• Analyse quality trends, drive continuous improvement and initiate new SOPs where needed.
• Design and deliver regular GxP training programmes for all employees.
• Collaborate with Business Development, development organisations and global QA to support product launches and ensure market release complies with specifications and regulations.

Required profile

• Scientific university degree.
• Minimum 5 years of experience in Quality Assurance and/or Regulatory affairs within the pharmaceutical industry.

Required skills