Corporate Quality Auditing Sr Specialist (Pharmaceutical)

TL;DR

Corporate Quality Auditing Sr Specialist (Pharmaceutical): Planning and performing international audits of GxP suppliers and contractors to ensure compliance with GMP, GDP, and ISO standards with an accent on supplier qualification and quality performance monitoring. Focus on conducting on-site audits across Europe and worldwide, drafting quality agreements, and managing corrective action plans.

Location: Must be based across Europe with regular travel to Parma, Italy

Company

International research-focused biopharmaceutical group with 90 years of experience and a certified B Corp status.

What you will do

• Plan and perform international GxP audits of suppliers and contractors autonomously.
• Draft quality agreements and ensure supplier qualification according to GMP, GDP, and ISO standards.
• Lead on-site audits across Europe and worldwide, preparing agendas and detailed reports in English.
• Monitor the progress and effectiveness of corrective actions following audits.
• Manage quality statements and participate in investigations of material non-conformities.
• Conduct component supplier validation for raw materials and packaging.

Requirements

• Minimum 5 years of hands-on experience as a GMP Auditor (lead or active co-auditor).
• Proven track record in supplier and contractor audits within the pharmaceutical industry.
• Deep knowledge of EU & FDA GMP (Eudralex, 21 CFR 210/211), GDP, and ISO standards.
• Degree in scientific disciplines (Pharmacy, Biology, Chemistry, etc.).
• Experience auditing sterile, biological, or biotechnological medicinal products.
• Proficiency in spoken and written English.

Nice to have

• Formal GMP Auditor certification (e.g., APIC, PDA, ECA).
• ISO 9001 auditor qualification.
• Experience auditing external manufacturing (CMOs) or global suppliers.

Culture & Benefits

• Competitive salary package comprising basic salary and performance bonuses.
• Flexible working arrangements and remote work options.
• Comprehensive healthcare programs and work-life balance initiatives.
• Robust relocation support and tax assistance for foreign colleagues.
• Dynamic, friendly environment with access to resources and training.