QA Compliance Expert

About the job

Salary Range:

€29,800.00 - €55,300.00

Job Description Summary

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.

Job Description

Major Accountabilities:

• Planning and supporting PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implementation of Quality Systems (incl. documentation management).
• Supplier management activities (agreements, oversight, audit).
• 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.

Essential requirements:

• 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.
• Strong collaborative attitude.
• Stakeholder management skills.
• 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:

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 & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

Audits Compliance, Collaboration, Communication, Data Integrity, Decision Making, Digital Fluency, 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