Quality Assurance Compliance Team Leader

Salary Range:

59300.00 - 110100.00

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 our team as Quality Assurance Compliance - Team Leader and play a key role in ensuring robust quality and compliance across our aseptic pharmaceutical manufacturing site. Reporting to the QA Compliance Lead you will help ensure all site and product-related activities comply with cGxP requirements Novartis Quality Standards and applicable international and local regulations supporting market access and the consistent delivery of high-quality medicines to patients. You will lead a team of Associate QA Compliance Experts manage resources and workload to deliver key objectives and coach develop and empower QMS professionals with the guidance tools and support needed to work effectively and independently.

In this role you will drive focus on key QMS processes and support the implementation of global Novartis processes at the Novartis Manufacturing NV site including deviations and escalations Annual Product Quality Review Management Review self-inspection document management and other critical quality processes. You will monitor and report key quality indicators to the global Novartis organization raise awareness strengthen site commitment and provide support and training where needed. You will also continuously evaluate QMS processes support improvement initiatives proactively identify quality and compliance risks escalate them to site senior management and the global organization as appropriate and help develop effective mitigation plans. Maintaining continuous audit readiness is a key responsibility with the QMS department acting as the single point of contact for FAGG TÜV and other regulatory authorities during GMP inspection coordination whether remote or on-site.

Job Description

Deadline for applications: 31st of July 2026.

Major Accountabilities:

• Implement and maintain global QMS processes.
• Ensure site and product compliance with guidelines legislation requirements and standards.
• Monitor and report key quality indicators to global Novartis stakeholders and drive site awareness ownership and commitment to quality performance.
• Identify and escalate quality and compliance risks and drive mitigation.
• Act as the site QMS point of contact for external regulatory and certification stakeholders Coordinate and support regulatory inspections and audits including remote and on-site inspections.
• Drive audit readiness across the manufacturing site by strengthening compliance culture supporting inspection preparation and ensuring QMS processes are effectively embedded.
• Provide guidance support and training to site teams on QMS processes compliance expectations and quality-related responsibilities.
• Strive for lean and effective QMS processes through optimization automation and synergy.
• Manage coach and develop the QMS team.
• Uphold a culture of ownership solution orientation constructive collaboration responsibility and efficiency.

Obligatory Requirements:

• Masters degree in a scientific field such as Pharmacy Industrial Pharmacy Bioengineering or related discipline.
• 5 years experience in a GMP environment preferably within the pharmaceutical asceptics industry.
• Previous leadership and/or QMS experience are a plus.
• Quality focused mindset
• Effective collaborator with various stakeholders through indirect leadership
• Expert in communication across all layers of the organization locally and globally.
• Process expert with an eye for operational excellence.
• Main language is Dutch fluency in English is required.

Rewards

At Novartis were 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 also offer a variety of competitive benefits inkindto help you thrive personally and professionally such as insurance plans retirement plans wellbeingresourcesand global recognition addition we provide flexible and hybrid working options where possible anda minimum of14 weekspaid parental leave.

Expected Annual Base Salary Range for role:

• Belgium: 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 ourbrochureto learn more about our global total rewards offering: 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 diverseteamsrepresentative 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. Collaboratingsupportingand inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together and Rewards:Read our handbook to learn about all the ways well help you thrive personally and professionally: Desired