R&D QA GCP Manager

Location: Based in Parma, Italy, with the possibility of a hybrid working arrangement.

Salary: €52,000 minimum per year, plus an annual performance-based bonus.

Company

Research-focused biopharmaceutical group developing and marketing innovative medicines across multiple therapeutic areas, with R&D operations in Europe, North America, and Asia.

What you will do

• Act as the QA GCP reference person for clinical project teams and provide quality input during study design, execution, and reporting.
• Ensure GCP compliance and support implementation and maintenance of GCP quality systems.
• Review clinical study documents, including protocols, amendments, patient information and informed consent materials, labels, instructions for use, and clinical study reports.
• Manage suspected serious breaches and GCP deviations.
• Prepare, manage, and follow up on GCP inspections by regulatory authorities.
• Write and review SOPs and work instructions for R&D QA GCP and clinical study activities.

Requirements

• At least 3 years of experience in clinical QA within a pharmaceutical company or clinical CRO, or alternatively at least 3 years of clinical study experience as a CRA or Project Manager.
• Scientific, pharmacy, or life sciences degree.
• Deep written and spoken English proficiency.
• Knowledge of GCP regulations.
• Proficiency with common office software.

Culture & Benefits

• Annual performance bonus and comprehensive benefits package.
• Pension, private medical insurance, wellbeing programme, flexible benefits, and meal vouchers.
• Professional development supported through training and access to resources.
• Work-life balance initiatives, flexible working arrangements, and remote work options within the hybrid setup.
• Relocation support and tax assistance services for foreign colleagues.