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

• 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.

Your profile

• 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.

Your motivation

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!