QA GMP Senior Auditor

Department: Global R&D Quality Assurance

Business Area: Quality

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

The role supports the execution of first and second party audits, the qualification and maintenance of R&D suppliers and service providers, and the definition and management of Quality Agreements.

The position includes a dedicated focus on sterile, biological and biotech products.

Experience in gene therapies or related advanced platforms is considered a plus.

• Plan and execute second party audits of GMP suppliers and GMP service providers (CMOs , contract laboratories).
• Execute first party audits.
• Monitor the follow-up of audit non-conformities and verify the adequacy and timely closure of corrective and preventive actions.
• Manage and coordinate external consultants supporting the Auditing & Supplier Qualification - GMP & Medical Device Unit.
• Define, review and finalise Quality Agreements with GMP suppliers and service providers.
• Support the hosting of GMP inspections.
• Collect and review data for Management Review and KPIs/ metrics.
• Finalize, review and standardise SOPs related to auditing and supplier/service providers qualification processes.
• Organise and support training on GMP requirements and related procedures.
• Act as QA reference for audit and qualification activities supplier/service providers involving sterile, biological and biotech products.
• Interact with CMC, Regulatory Affairs, Clinical Supply, Procurement and other cross-functional teams to what concerns qualification of the above listed providers.

• Scientific degree, preferably in Pharmacy, Chemistry, Biology, Biotechnology, Pharmaceutical Sciences or a related scientific discipline.
• At least three years of experience as auditor in pharmaceutical companies.
• Experience in Quality Assurance, supplier qualification or audit activities within pharmaceutical development and/or manufacturing environments.
• Knowledge of GMP requirements
• Knowledge of auditing techniques
• Knowledge of sterility assurance principles and GMP compliance expectations for sterile and biotech products.
• Leadership, organisational skills, stress management, independent judgement and objectivity, team working, networking, decision making, listening skills and orientation to efficiency.
• Fluent English, written and spoken.
• Good knowledge of Microsoft Office tools, including Word, Excel, Outlook and PowerPoint.

• Experience in sterile manufacturing, biotech or biological product environments is strongly preferred.
• Consider experience in gene therapies, advanced therapy medicinal products, viral vectors, cell-based products as an additional advantage.
• Familiarity with EDMS and other QMS IT systems is preferred.