Senior QA GCP Specialist and Auditor

Job description

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 This is what you will do Who we are looking for The role will be responsible 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 at clinical studies and vendors. 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/Quality Management system, Suppliers and Audit workflows Support the management of external consultants supporting the Auditing, Due Diligence & Supplier Qualification Unit. Finalization of Quality Documents supporting the Auditing, Due Diligence & Supplier Qualification Unit. Write/Review SOPs relating to audit and qualification of clinical service providers Ensure training on GCP relevant activities and procedures Ensure good documentation and traceability Execution of GCP first and second party audits at clinical studies and vendors Finalization and management of the GCP audit reports Interact with Clinical Departments, Pharmacovigilance and Procurement 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 At least 2 years of experience as GCP auditor Knowledge of GCP requirements and quality system Knowledge of the pharmaceutical development process supporting the whole panel of clinical trials (Phase I, II, III and IV) Knowledge of training technique Knowledge of auditing technique Scientific degree Fluent English, written and spoken Planning and organizational skills Strategic thinking Team working Quality orientation Communication skills Location The position is based at our headquarters in Parma and offers a flexible hybrid working arrangement. Compensation Range The budgeted salary range approved for this role is between € 52.000 and € 65.500. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, 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. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. 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.