GCP Specialist R&D (Biopharma)

TL;DR

GCP Specialist R&D (Biopharma): Ensuring compliance and correct application of Good Clinical Practices within the Global R&D Departments with an accent on CAPA management and quality metrics. Focus on executing first and second party audits, managing audit workflows, and maintaining SOPs for clinical service providers.

Location: Parma, Italy (Hybrid)

Salary: from € 46,000

Company

International research-focused biopharmaceutical group and certified B Corp dedicated to promoting a healthier world through innovative drug development.

What you will do

• Manage GCP CAPA plans and quality metrics (KPIs) to support compliance inside Global R&D Departments.
• Execute first and second party GCP audits and manage the finalization of audit reports.
• Oversee Trackwise, suppliers, and audit workflows.
• Write and review SOPs relating to the audit and qualification of clinical service providers.
• Coordinate with external consultants supporting the Auditing & Supplier Qualification Unit.
• Ensure rigorous documentation, traceability, and training on relevant procedures.

Requirements

• At least 3 years of experience in QA within Pharmaceutical, Consultancy, or CRO R&D environments.
• Robust knowledge of GCP requirements and quality systems supporting clinical trials.
• Scientific degree.
• Good knowledge of English.
• Must be based in or be able to relocate to Parma, Italy.

Nice to have

• Knowledge of auditing techniques.
• ISO auditor Certification.

Culture & Benefits

• Comprehensive benefits package including pension, private medical insurance, and a wellbeing programme.
• Competitive salary with an annual performance-based bonus scheme.
• Flexible working arrangements and remote work options.
• Robust relocation support and tax assistance services for foreign colleagues.
• Commitment to diversity, inclusion, and sustainable innovation.