GCP specialist R&D Auditing Department

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.

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).

What you will do

To verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by execution of first and second party audits.

You will be responsible for

• Management of CAPA Plans from GCP audits
• Management of the requests for the collection of quality metrics, KPIs supporting Global R&D Departments
• Management of Trackwise, Suppliers and Audit workflows
• Support the management of external consultants supporting the Auditing & Supplier Qualification Unit.
• Finalization of Quality Documents supporting the Auditing & Supplier Qualification Unit.
• Write/Review SOPs relating to audit and qualification of clinical service providers
• Ensure training on relevant activities and procedures
• Ensure good documentation and traceability
• Execution of GCP first and second party audits
• Finalization and management of the GCP audit reports

You will need to have

• At least 3 years’ experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance
• Knowledge of GCP requirements and quality system
• Knowledge of the pharmaceutical development process supporting clinical trials
• Knowledge of training technique
• Good knowledge of English.

We would prefer for you to have

• Knowledge of auditing technique to be considered an added value
• ISO auditor Certification to be considered an added value

Location

ThepositionisbasedatourheadquartersinParmaandoffersaflexiblehybridworkingarrangement.

Compensation Range

The minimum salary for this role is € 46.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.