Associate QA Compliance Expert - QMS

Job Description Summary

#LI-Hybrid
Location: Puurs, Belgium
Internal job title: Associate QA compliance Expert

Join the QA compliance team and help ensure robust compliance, monitor key quality indicators (KQI) and effective implementation of the Novartis Quality Management System. In this role, you will safeguard that all site and product-related activities meet cGxP requirements including data integrity, Novartis quality standards, and applicable international and local regulations, supporting the consistent delivery of high-quality medicines to patients.
You will act as a site subject-matter expert in your designated area such as data integrity, audit and inspection management, deviation investigations partnering closely with Manufacturing, QC laboratories, MS & T, Supply Chain, QA departments and external partners. Through your contributions to investigations, CAPAs, audits and inspections, and continuous improvement, you will strengthen compliance, make a meaningful impact across our operations and for the people relying on our medicines.

 

Job Description

Key Responsibilities:

• Ensure the site Quality Management System remains compliant with cGxP requirements, including data integrity

• Implement, maintain, and continuously improve QMS processes and governance, aligned with Novartis standards and applicable regulations.

• Review, coordinate, and drive timely completion of deviations, investigations, CAPAs, and effectiveness checks, with strong focus on preventing recurrence.

• Plan, coordinate, and oversee APQR execution, ensuring timely completion, clear outcomes, and appropriate follow-up.

• Prepare for, support, and coordinate internal and external audits and regulatory inspections, including readiness activities and response follow-up.

• Provide clear explanations of QMS processes during internal and external audits.

• Maintain site licenses up to date and compliant with FAGG requirements

• Keep assigned procedures accurate, updated, and aligned with evolving operational requirements.

Essential Requirements:

• Master’s degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.

• Experience in a regulated environment, preferably within the pharmaceutical industry.

• Strong understanding of Good Manufacturing Practices and relevant pharmaceutical legislation.

• Proficiency in computer systems with the ability to work accurately with digital documentation.

• Excellent communication skills with the ability to collaborate effectively across teams and with external partners.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

 

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Problem Solving Skills, Regulatory Requirements knowledge