Associate Quality Assurance Compliance Expert - QMS

Novartis; Puurs-Sint-Amands; Hybrid; EUR 51,000 - 94,000; Full time

Benefits offered by this job

Hybrid work

Parental leave

Insurance plans

Job summary

Novartis in Puurs, Belgium, is seeking a QA compliance expert to ensure the Quality Management System stays compliant with cGxP requirements, including data integrity and regulatory alignment. You will act as a site SME for data integrity, audits, and CAPAs, collaborating with Manufacturing, QC labs, MS&T, Supply Chain, QA, and external partners to strengthen compliance.

Join a role focused on investigations, CAPAs, audits, continuous improvement, and readiness activities, contributing to

Qualifications

• Master’s degree in a scientific field such as Pharmacy, Industrial Pharmacy, Bio‑engineering, or related discipline.
• 3+ years of 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.
• Fluent Dutch and English, written and spoken.

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.

Skills

Data integrity

Audits

CAPA

Documentation

Communication

Education

Master’s degree in a scientific field (Pharmacy/Industrial Pharmacy/Bio-engineering)

Tools

Computer systems proficiency

Job description

Salary Range:

€50,800.00 - €94,400.00

Job Description Summary

#LI-Hybrid

Location: Puurs, Belgium

Relocation Support: This role is based in Puurs, Belgium. Novartis is unable to offer relocation support: please only apply if accessible.

Join the QA compliance team and help ensure robust compliance 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

Deadline for applications: 27th October 2026.

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.


• 3+ years of 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.


• Fluent Dutch and English, written and spoken.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits inkindto help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeingresourcesand global recognition programs. In addition, we provide flexible and hybrid working options, where possible, anda minimum of14 weekspaid parental leave.

Expected Annual Base Salary Range for role:

• Belgium: 50,800 – 94,400 EUR

The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph:

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

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating,supportingand inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Skills Desired

Audits Compliance, Collaboration, Communication, Data Integrity, Decision Making, Internal Auditing, Managing Ambiguity, Problem Solving, Process Quality Assurance, Quality Assurance (QA), Quality Auditing, Quality Compliance, Quality Management, Quality Management System Implementation, Regulatory Compliance, Validation Activities, Validation Management