Corporate Quality Auditing Senior Specialist

TL;DR

Corporate Quality Auditing Senior Specialist (Pharma): Conducting GMP/ISO audits, supplier qualification, and validation for global GxP contractors and suppliers with an accent on quality oversight in sterile and biological medicinal products manufacturing. Focus on planning and executing audits worldwide, monitoring corrective actions, and maintaining quality procedures and agreements.

Location: Parma, Italy (flexible working arrangements and remote work options available, robust relocation support and tax assistance for foreign colleagues)

Company

International research-focused biopharmaceutical group with 90 years’ experience, operating in 30+ countries, headquartered in Parma, Italy, with 8,000+ employees focused on innovative drugs in main therapeutic areas.

What you will do

• Carry out GMP/ISO audits of GMD contractors autonomously and conduct audits in Europe and worldwide.
• Draft quality agreements, audit reports in English, and synoptic tables on audit status.
• Ensure supplier qualification, validation, and monitoring of global suppliers' quality performance per GxP and hirify.global standards.
• Participate in non-conformity investigations, change control evaluations, and maintenance of quality statements from GxP suppliers.
• Update procedures for GxP audits, supplier qualification, validation, and quality risk management.
• Validate component suppliers and qualitatively evaluate contractors with procurement teams.

Requirements

• Degree in scientific disciplines (Pharmacy, CTF, Biology, Chemistry, etc.).
• 5+ years experience in auditing activities of sterile, biological medicinal products.
• Good spoken and written English.
• Knowledge of national/international pharmaceutical legislation (e.g., DL 219, Eudralex Vol.IV, 21CFR parts 210/211).
• Expertise in pharmaceutical/sterile/biotechnology products manufacturing and control, auditing practices, and supplier quality assurance.

Nice to have

• Auditor qualification or QP certification.
• ISO 9001:2015 Corporate Quality Systems evaluator qualification.
• GMP Auditor qualifications or certificates from APIC, PDA, ECA, etc.

Culture & Benefits

• Comprehensive healthcare programs, work-life balance initiatives.
• Competitive salary with performance bonuses, benchmarked against market.
• Flexible working arrangements, remote work options.
• Development resources, training, and inspiring career possibilities.
• Diversity, inclusion, sustainability focus as a B Corp.