Experteer Overview

In this role you ensure GCP compliance across Global R&D; by managing CAPAs, quality metrics, and audit programs. You will drive the documentation and process controls that support audit readiness and supplier qualification. You work closely with cross-functional teams to sustain a robust quality system and enable compliant clinical trials. The position offers a hybrid setup at the Parma HQ within a values-driven, sustainability-minded organization.

Responsibilities

- Manage GCP CAPA plans and follow-up
- Coordinate collection of quality metrics and KPIs for Global R&D;
- Oversee Trackwise, supplier, and audit workflows
- Support external consultants in the Auditing & Supplier Qualification Unit
- Finalize Quality Documents for the unit
- Write/Review SOPs related to audit and qualification of clinical service providers




- Provide training on relevant activities and procedures
- Ensure documentation traceability and audit report finalization

Qualifications

- At least 3 years of experience in Pharmaceutical, Consultancy, or CRO in Quality Assurance for R&D; with strong GCP knowledge
- Knowledge of GCP requirements and quality systems
- Understanding of the pharmaceutical development process supporting clinical trials
- Experience with training techniques
- Scientific degree
- Good knowledge of English

Benefits

- pension
- private medical insurance
- wellbeing programme
- flexible benefits programme
- remote work options
- relocation support

#J-18808-Ljbffr

📌 GCP specialist R&D Auditing Department (Parma)
🏢 Experteer Italy
📍 Parma