Senior Quality Assurance GDP Specialist (Pharmaceuticals)

TL;DR

Senior Quality Assurance GDP Specialist (Pharmaceuticals): Managing and strengthening the Good Distribution Practice (GDP) Quality Management System with an accent on regulatory compliance and risk-based decision making. Focus on managing deviations, CAPA, change control, and ensuring product quality and patient safety across the supply chain.

Location: Primary location is Parma (Italy). Candidates can be based across Europe, but regular travel to Parma is required.

Salary: Minimum € 46,000 + annual bonus.

Company

International research-focused biopharmaceutical group operating in over 30 countries with a focus on sustainable innovation and healthcare.

What you will do

• Support the definition, implementation, and continuous improvement of Quality Systems aligned with GDP requirements.
• Manage core quality processes including Deviations, CAPA, Change Control, and Distribution Complaints.
• Execute internal, supplier, and customer audits, as well as supplier qualification.
• Review temperature excursions and assess suitability for product release or rejection.
• Oversee recall operations and manage returned, rejected, or falsified products.
• Represent the GDP Quality department in internal and external meetings and support regulatory inspections.

Requirements

• Qualification in a scientific or technical discipline and/or 8+ years of relevant industry experience.
• Deep knowledge of Quality standards and Regulatory guidelines for pharmaceutical or biotech products.
• Proven experience in managing GDP quality activities, risk management, and problem-solving.
• Ability to work autonomously and make timely, risk-based decisions.
• Must be based in Europe with the ability to travel regularly to Italy.

Nice to have

• Experience working with pharmaceutical products for rare diseases (orphan drugs).
• Comfort working in an environment where the QMS is expanding to support company growth.

Culture & Benefits

• Comprehensive healthcare programs and private medical insurance.
• Annual performance-based bonus scheme.
• Robust relocation support and tax assistance services for foreign colleagues.
• Flexible working arrangements and remote work options.
• Pension plan, wellbeing programs, and a flexible benefits package.