Development Quality Assurance Manager

Novartis; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Development QA Manager in Milan to ensure GCP and GPV compliance in clinical studies and oversee QA investigations. The ideal candidate will have a degree in Life Sciences, over 5 years of experience, and fluency in English. This role emphasizes quality improvement, risk management, and collaboration with various teams within the organization.

Servizi

Commitment to Diversity & Inclusion

Competenze

• Fluent in English (speaking and writing).
• Typically more than 5 years of experience in the pharmaceutical industry in relevant fields such as quality assurance or regulatory affairs.

Mansioni

• Support and monitor the implementation of the local Quality Plan (QP) related to GCP and PV.
• Ensure adequate training systems for GCP, GPvP, and maintain inspection-ready documentation.
• Lead clinical/PV QA investigations to ensure robust CAPA plans are implemented.
• Monitor quality systems to proactively identify risks.
• Lead or support GCP and GPvP inspections.
• Approve local CAPAs and ensure timely closure.
• Oversee qualification of ESPs supporting clinical/medical or PV activities.
• Maintain processes for digital systems with GCP/GPvP impact.
• Lead local quality review meetings and communicate trends/risks.

Formazione

Degree in Life Sciences or related fields

Descrizione del lavoro

220 is the number of clinical studies in which Novartis Italy is participating, providing innovative medication and treatments for more than 1200 patients. Do you want to contribute to innovation and ensure the best quality for our patients?

As a Development QA Manager, you will be responsible for ensuring GCP and GPV compliance in clinical studies and other post-marketing projects with local regulations and global standards. You will support and collaborate with more than 140 employees in GDD and medical functions. Italy is a key country for Novartis in development, with increasing importance in the number of clinical studies and patients.

Your key responsibilities

• Quality Plan and Continuous Improvement: Support and monitor the implementation of the local Quality Plan (QP) related to GCP and PV, ensuring alignment with global QP chapters. Use lessons learned from audits, inspections, KQI reviews, and daily quality oversight to recommend and initiate improvements.
• Training Systems: Ensure adequate training systems are in place for GCP, GPvP, and other relevant activities, maintaining inspection-ready documentation to support reviews of training compliance.
• Quality Issue Management: Lead clinical/PV QA investigations and ensure robust CAPA plans are implemented. Escalate GCP/GPvP non-compliance issues as necessary.
• Risk Identification and Management: Monitor quality systems and KQIs to proactively identify risks. Collaborate to review root causes and impacts, and ensure mitigation plans are in place.
• Inspection Management and Support: Lead or support GCP and GPvP inspections, ensuring timely responses and closure of CAPAs.
• CAPA Management: Approve local CAPAs and ensure ownership and timely closure by responsible functions.
• ESP/Supplier Management: Oversee qualification/requalification of ESPs supporting clinical/medical or PV activities, ensuring proper processes are followed.
• Data Integrity: Maintain processes for digital systems and platforms with GCP/GPvP impact.
• Governance and Communication: Lead local quality review meetings, communicate trends/risks, and coordinate with stakeholders. Maintain business continuity plans for GCP and GPvP.
• Commitment to Diversity & Inclusion: We aim to build an inclusive, diverse work environment reflecting the communities we serve.

Minimum requirements

• Degree in Life Sciences or related fields
• Fluent in English (speaking and writing)
• Typically more than 5 years of experience in the pharmaceutical industry in relevant fields such as quality assurance or regulatory affairs