Quality System & Compliance Manager

for the site Borgo San Michele LT, Italy

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing \- that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.Your key responsibilities
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• Ensure the maintenance and effectiveness of the site's GMP quality system.


• Guarantee the management and oversight of Change Control, CAPA, GMP documentation, training, and GMP supplier management processes.


• Ensure planning and execution of the internal audit program and manage regulatory and customer inspections.


• Coordinate overall Risk Management process according to ICH Q9 guidelines.


• Monitor and communicate quality system and compliance KPIs, supporting the Quality System Review.


• Support alignment with global functions and implementation of company best practices.


• Guarantee the maintenance of quality culture and support continuous improvement initiatives.


• Analyze quality system data to identify trends, risks, and improvement opportunities.


• Collaborate with HR for GMP training definition and monitoring, and personnel training compliance.


• Manage the preparation, execution, and follow\-up of regulatory inspections and customer audits.

• Degree in scientific disciplines (Pharmacy, Chemistry, Biology, or equivalent).


• At least 5 years of experience in Quality Assurance / Quality Systems in pharmaceutical GMP environments.


• People magement experience.


• Strong knowledge of EU and FDA GMP regulations.


• Data analysis and management skills.


• Fluent in English and Italian.


• Continuous improvement mindset.


• Critical thinking and quality orientation.


• Proactivity and decision\-making ability.


• Effective communication and cross\-functional collaboration.

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get\-it\-done" culture and think in terms of solutions rather than problems? What are you waiting for? We would be happy to explain our corporate benefits in a personal conversation!
If you have any questions, I \- Chiara Fanasca / Human Resources \- will be happy to help you: Chiara.Fanasca@aenova\-group.com

Online seit: 03\.06\.2026* Beschäftigungsverhältnis

Vollzeit

• Unternehmen

• Bereich

Kontakt
Haupt Pharma Latina S.r.l. • Member of the Aenova Group • Strada Statale 156 dei Monti Lepini • 04100 Borgo San Michele LT‚ Italy

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