Quality Assurance Operations Lead

Salary Range:

57900.00 - 107500.00

Job Description Summary

#LI-Onsite
Location: Colleretto Giacosa (Ivrea) Italy

This role is based in Ivrea Italy. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

The Quality Assurance Operations Lead is responsible for ensuring the release of products manufactured in compliance with the Quality System current registrations and applicable regulatory standards. This includes guaranteeing that sterile injectable products meet GMP FDA AIFA Novartis Quality Manual and other relevant quality requirements while ensuring site operations remain fully compliant.

The position provides quality oversight of manufacturing activities manages the human and technical resources of the Quality Assurance Operations department and ensures effective QA support for the sites commercial operations.

Job Description

Deadline for applications: 18th of September 2026.

Major Accountabilities:

• Lead the implementation and continuous improvement of compliance with applicable quality standards including GMP FDA AIFA the Novartis Quality Manual and site quality procedures while promoting a strong quality culture across the organization.
• Oversee QA Operations activities including product release documentation management SOP approval training resource planning shift organization for QPs and QA Officers and professional development of team members.
• Ensure quality oversight of manufacturing operations maintenance qualification calibration revalidation process validation cleaning validation equipment qualification and new projects requiring QA Operations support.
• Manage and approve quality processes including OOS OOT OOE deviations change controls CAPA complaints recalls returns investigations and related corrective and preventive actions in accordance with cGMP and SOPs.
• Ensure timely escalation and communication of quality and cGMP issues non-conformities product-impacting incidents and substantial irregularities involving products already placed on the market including communication to relevant internal stakeholders and competent authorities when required.
• Support audits inspections and quality reviews by participating in authority and corporate audits annual self-inspection planning annual training planning and Annual Product Quality Review preparation and review.
• Monitor report and drive quality performance by tracking assigned indicators ensuring projects and responsibilities are completed on time and supporting business continuity in collaboration with Site Management Quality Quality Control and Production leaders.
• Provide QA support to commercial operations while ensuring compliance with environmental safety order cleanliness internal communication and external communication requirements within the area of responsibility.

Obligatory Requirements:

• Scientific degree in Pharmacy Chemistry or Biology.
• 5 years of experience in the pharmaceutical industry with strong knowledge of QA Operations and quality requirements.
• Strong understanding of cGMP regulations regulatory requirements and pharmaceutical quality standards.
• Solid knowledge of aseptic processes and aseptic manufacturing practices.
• Excellent organizational skills attention to detail teamwork mindset and ability to work with urgency on assigned tasks.
• Strong communication and collaboration skills with the ability to support smooth and safe production operations drive productivity improvements through new technologies and processes.
• Fluent in Italian and English both written and spoken.

Desirable Requirements:

• Experience in a high-tech production environment as a Qualified Person is highly valued.

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:EUR 57900.00 - 107500.00 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

Analytical Thinking Business Acumen Change Management Collaboration Communication Continuous Improvement Leadership Managing Ambiguity Quality Assurance (QA) Quality Compliance Quality Control (QC) Quality Management Quality Management Systems (QMS) Risk-Based Decision Making Risk Management Stakeholder Management Storytelling Supplier Quality Management