R&D QA GCP Manager (Pharmaceuticals)

TL;DR

R&D QA GCP Manager (Pharmaceuticals): Ensuring GCP compliance within clinical project teams and maintaining quality systems with an accent on clinical study design, execution, and reporting. Focus on managing suspected serious breaches, GCP deviations, and supporting regulatory inspections.

Location: Based in Parma, Italy (Hybrid)

Company

International research-focused biopharmaceutical group with 90 years of experience operating in over 30 countries.

What you will do

• Act as the QA GCP reference person for clinical project teams, supporting study design, execution, and reporting.
• Ensure GCP compliance and implement/maintain quality systems within GCP areas.
• Review clinical study documentation, including protocols, amendments, and patient information sheets.
• Manage suspected serious breaches and GCP deviations.
• Support the preparation and management of GCP inspections from regulatory authorities.
• Develop and review SOPs and working instructions for R&D QA GCP activities.

Requirements

• At least 3 years of experience as Clinical QA, CRA, or Project Manager in pharmaceutical companies or CROs.
• Scientific degree in Pharmacy or Life Sciences.
• Deep knowledge of English (both oral and written).
• Strong understanding of GCP regulations.
• Proficiency in common computer tools.

Culture & Benefits

• Comprehensive healthcare programs and work-life balance initiatives.
• Robust relocation support.
• Competitive salary package with performance bonuses.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.