Quality Assurance Expert

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl; Saluggia; Hybrid; EUR 30,000 - 55,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid work options

Parental leave

Job summary

Novartis AG in Saluggia, Italy, is seeking a Quality Assurance Expert to safeguard GMP standards across manufacturing. You will collaborate with cross‑functional teams to strengthen processes, support audits, and drive continuous improvement at the Saluggia site.

The role requires a university degree in a scientific discipline, at least 1 year in a quality department, and fluent English. A hybrid working setup is available, with emphasis on inspection readiness and regulatory compliance.

Qualifications

• University degree in a scientific discipline.
• At least 1 year in a Quality department, preferably in a regulated environment.
• Good knowledge of GMP and Quality Management System principles.
• Fluency in English, both written and spoken.

Responsibilities

• Ensure manufacturing activities comply with Good Manufacturing Practice, regulatory requirements, quality standards, and approved procedures.
• Review and approve batch records, specifications, control methods, protocols, and Quality Management System documentation.
• Manage deviations, corrective and preventive actions, and change controls, ensuring robust investigation and timely resolution.
• Review investigations involving out-of-specification, out-of-trend, out-of-expectation results, and system suitability test failures.
• Manage product complaints and support supplier qualification activities in line with established quality requirements.
• Prepare Annual Product Quality Reviews and contribute to the development and maintenance of the Site Master File.
• Support internal audits, self-inspections, and Health Authority inspections, ensuring strong inspection readiness.
• Partner with cross-functional teams to improve manufacturing processes, quality performance, productivity, and operational effectiveness.

Skills

Attention to detail

Organizational skills

Collaboration

English proficiency

Education

University degree in a scientific discipline

Job description

Salary Range: €29,800.00 - €55,300.00 Band Level 3

Job Description Summary #LI-Hybrid Location: Saluggia, Italy Relocation Support: This role is based in Saluggia, Italy. Novartis is unable to offer relocation support: please only apply if accessible.

Quality is what turns scientific innovation into reliable impact for patients. As a Quality Assurance Expert, you will help safeguard high standards across manufacturing by ensuring alignment with Good Manufacturing Practice, regulatory requirements, and the Quality Management System. You will work closely with cross‑functional teams to strengthen processes, manage key quality activities, support audits and Health Authority inspections, and contribute to the continuous improvement of the Saluggia site. This is an opportunity to bring your quality mindset, attention to detail, and collaborative approach to a role with meaningful impact across our operations.

Key Responsibilities

• Ensure manufacturing activities comply with Good Manufacturing Practice, regulatory requirements, quality standards, and approved procedures.
• Review and approve batch records, specifications, control methods, protocols, and Quality Management System documentation.
• Manage deviations, corrective and preventive actions, and change controls, ensuring robust investigation and timely resolution.
• Review investigations involving out‑of‑specification, out‑of‑trend, out‑of‑expectation results, and system suitability test failures.
• Manage product complaints and support supplier qualification activities in line with established quality requirements.
• Prepare Annual Product Quality Reviews and contribute to the development and maintenance of the Site Master File.
• Support internal audits, self‑inspections, and Health Authority inspections, ensuring strong inspection readiness.
• Partner with cross‑functional teams to improve manufacturing processes, quality performance, productivity, and operational effectiveness.

Essential Requirements

• University degree in a scientific discipline.
• At least 1 year of experience in a Quality department, preferably within a regulated environment.
• Good knowledge of Good Manufacturing Practice and Quality Management System principles.
• Basic knowledge of relevant regulatory requirements and their application within quality operations.
• Fluency in English, both written and spoken.
• Strong organizational skills, attention to detail, collaborative mindset, and ability to prioritize tasks with appropriate urgency.

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 in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.

In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.

Expected Annual Base Salary Range for role: EUR 29,800-55,300. 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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ 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, supporting and 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

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.