Global R&D QA, Senior Validation, Digital & Data Integrity Specialist

About usChiesi 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.

Sebbene l'esperienza professionale e le qualifiche siano fondamentali per questo ruolo, si assicuri di verificare di possedere le soft skill preferenziali, se richieste, prima di candidarsi.

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 & DevelopmentOur 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 forThis is what you will doThe Global R&D QA, Senior Validation, Digital & Data Integrity Specialist ensures the maintenance in a state of control and validation of software systems involved in GXP process. Ensures Project Management for relevant projects.

You will be responsible forCoordination and supervision of the validation of computerized systems, particularly considering the impact of new digital technologies in the GxP environment (Validation Manager for Computerized Systems).Drafting validation procedures, validation plans (VPP), related summaries (VSR), and periodic validation reviews (PVR) in the software domain.

Reviewing and approving, in the software domain: URS, functional specifications, qualification reports, and software procedures.

Managing changes, deviations, and CAPAs related to software systems. Participating as a Technical Expert, with regard to validation aspects, in internal and external audits, including audits of software suppliers and especially clinical service providers, and supporting the related follow-up. Promoting adequate awareness among personnel involved in the use of software systems regarding CSV and Data Integrity aspects.

Conducting and supporting training related to procedures and regulations connected to software validation and Data Integrity topics.

Reviewing or approving SOPs related to software systems in accordance with regulations and company procedures.

Supporting risk phases as Risk Coordinator for software quality aspects (drafting or reviewing Risk Assessment Reports, reviewing Risk Management Reports, Risk Review Reports).Acting as the CSV point of contact during authority inspections.

Supporting the collection and assessment of QMS KPIs for the proper areaYou will need to haveAt least 5 years of experience in validation of computerized systems (CSV) in the pharmaceutical industryExcellent knowledge of all activities necessary for Computer Systems ValidationGood knowledge of European and U.S. quality regulations and main pharmaceutical industry guidelines (CFR 21 Part 11, EU GMP Annex 11, MHRA, WHO; ICH E6, GAMP5 Second Edition)Excellent understanding of Data Integrity principlesGood knowledge of Risk Management techniquesFluent EnglishWe would prefer for you to haveExperience in CSV in clinical development and knowledge of ICH E6 are strongly preferredLocationParma, ItalyCompensation Range The minimum salary for this role is 52.000, 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.

What we offerNo 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. xlwpduy This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.