QA Compliance Expert

IT08 (FCRS = IT008) Novartis Farma S.p.A.; Torre Annunziata; Hybrid; EUR 30.000 - 55.000; Vollzeit

Benefits dieser Stelle

Hybrid working options

Parental leave (14+ weeks)

Insurance plans

Zusammenfassung

Novartis Farma S.p.A. is seeking a QA Compliance professional to oversee quality systems, data integrity and regulatory compliance across key site activities in Italy. You will manage PQR/APQR, supplier oversight, CAPA, audits, and change controls, ensuring GMP adherence.

Fluency in Italian and English and 3–5 years in QA are required. The role emphasizes collaboration, training oversight, and timely reporting of adverse events, with a hybrid working model and competitive compensation in line

Qualifikationen

• University degree in a relevant field.
• 3–5 years of experience in a QA Compliance role within the pharmaceutical industry.
• Strong collaborative attitude and stakeholder management skills.
• Fluent in Italian and English.

Aufgaben

• Plan and support PQR/APQR activities.
• Support site qualification and validation activities (planning, advising, review).
• Implement Quality Systems (documentation management).
• Oversee supplier management (agreements, oversight, audit).
• Prepare/support CAPA and follow-up.
• Assist audits and inspections preparation and support.
• Review/approve change controls.
• Ensure local DI and eCompliance oversight (training, inspections, risk ID).
• Report technical complaints/adverse events related to Novartis products within 24 hours.

Kenntnisse

QA Compliance

Audits

Data Integrity

Regulatory Compliance

Validation

Quality Management

Ausbildung

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

Jobbeschreibung

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.

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.

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

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.