Job Description

THE POSITION

The Quality Assurance Operations Manager is responsible for implementing, maintaining, and continuously improving the Pharmaceutical Quality System (PQS) at a veterinary vaccine manufacturing site, ensuring full compliance with GMP requirements and BI AH global quality standards.

The role ensures that all quality systems, operational processes, and manufactured or distributed products remain in a state of control.

The QAOs Manager leads the QA Operations team, supports regulatory compliance, drives quality culture, and ensures alignment with the global quality network and the site mission.

Responsibilities:

• Ensure implementation, maintenance, and continuous improvement of Quality Systems in alignment with GMP (Eudralex Vol. 4, Annex 1, 2, 11) and quality guidelines; Maintain and promote a strong Quality Culture by ensuring an effective QMS across the site.
• Ensure compliance with cGMP, local regulations, and Corporate Quality requirements.
• Guarantee Data Integrity compliance and act as interface for computer system management and validation; Review and approve Master Batch Records, specifications, and key GxP documents; ensure documentation accuracy, compliance, and data integrity.
• Participate in internal and regulatory audits and inspections, providing documentation support and subject matter expertise; uphold high standards of traceability and completeness.
• Manage deviations, CAPAs, and change controls in alignment with GMP and Corporate procedures.
• Oversee root‑cause analysis and complaint investigations; support GMP‑relevant projects; act as Self‑Inspection System Owner; ensure timely batch record review; maintain inspection readiness; ensure compliance with internal procedures, safety (D.Lgs. 81/2008), environmental and biosafety requirements; promote quality, safety, and biosafety culture.

Requirements:

• Education: Degree in Pharmacy, Biotechnology, Chemistry, Biology, Veterinary Medicine, or another relevant Life Science discipline. Qualification as Qualified Person (QP) highly preferred.
• Minimum 5–7 years of experience in Quality Assurance within the pharmaceutical, biopharmaceutical, or veterinary vaccine industry.
• Experience managing QA teams: Experience leading QA teams and supporting QA Operations on the shopfloor is highly preferred.
  Technical Knowledge: Strong knowledge of EU GMP guidelines and relevant Annexes, quality systems, and operational compliance requirements.
• Expertise: Experience with deviation investigations, CAPA management, change control, risk management, data integrity, and batch record review; familiarity with global corporate quality systems and digital quality tools.
• Skills: Excellent leadership, communication, and stakeholder‑management abilities; strong analytical and problem‑solving skills with a risk‑based approach.
• Languages: fluent in English/Italian (spoken and written).

What we offer:

• For this position we offer a permanent contract.
• Free access to the company canteen.
• A range of benefits for you physical, financial, social and mental wellbeing.
• A support to develop your own professional and personal path that will guide you through our full range of development programs including our full range of development programs.

We warmly welcome applications from candidates belonging to protected categories, in accordance with Law 68/99.

We foster a workplace built on respect, trust, and empathy—free from discrimination.

We are powered by our people, and we believe that our differences are our strengths. Everyone is valued, respected and empowered to be themselves.