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.

Strong knowledge of EU and FDA GMP regulations.

Data analysis and management skills.

Fluent in English and Italian.

Critical thinking and quality orientation.

Proactivity and decision-making ability.

Effective communication and cross-functional collaboration.

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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