QA Compliance Expert

Novartis AG; Rovigliano; Hybrid; EUR 30,000 - 55,000; Full time

Benefits offered by this job

Hybrid work options

Parental leave 14 weeks

Wellbeing programs

Job summary

Novartis AG seeks a QA Compliance professional to oversee quality systems, qualification, validation, CAPA and audits at the site. You will monitor data integrity and ensure regulatory alignment while supporting CAPA and change control activities.

The role requires a university degree in a related field and 3-5 years of QA experience in pharma, with fluency in Italian and English to communicate across teams.

Qualifications

• 3-5 years of experience in a QA Compliance role within the pharmaceutical industry.
• Fluent in Italian and English.

Responsibilities

• Provide Quality Compliance oversight across site activities and KPI trending.
• Support PQR/APQR, qualification and validation, and change control.
• Coordinate CAPA/follow-up and audit/inspection readiness.
• Ensure local DI and eCompliance oversight (training, inspections, risk ID).
• Ensure process quality assurance in line with GMP and regulatory requirements.

Skills

Quality Assurance

Regulatory Compliance

GMP knowledge

Risk assessment

Audits & inspections

Education

University Degree in Pharmacy/Biotechnology/Chemical Sciences or related field

Tools

CAPA system

Job description

Provides Quality Compliance oversight across key site activities, including Quality Systems, qualification and validation, Data Integrity and eCompliance. Supports PQR/APQR, supplier management, CAPA, change control, audits and inspections, ensuring adherence to GMP and regulatory requirements. Monitors compliance performance through KPI trending and promotes continuous improvement.

About the Role

Major Accountabilities:

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management).
• Preparation/support and coordination of CAPA/follow-up.
• Audit and inspection preparation and support.
• Change control review/approval.
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.).
• Ensure process quality assurance acc. to regulations.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• University Degree in Pharmacy, Biotechnology, Chemical Sciences or a related field.
• 3-5 years of experience in a QA Compliance role within the pharmaceutical industry.
• Fluent in Italian and English.

Benefits & Rewards

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

Expected Annual Base Salary Range for role: 29.800,00 - 55.300,00 EUR

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

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 minimum 14 weeks paid parental leave.

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:

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 & Inclusion:

We are 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