Senior Quality Assurance GDP Specialist (Parma, IT)

ph3About us /h3pChiesi 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. /ppAt 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. /ppDiversity 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. /ph3Global Technical Operations Supply /h3pGlobal Technical Operations Supply (Global TechOpS) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain.

Global TechOpS oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement.

This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners. /ph3This is what you will do /h3pWe are seeking an experienced and highly motivated Senior GDP QA Specialist to support and strengthen our Good Distribution Practice (GDP) Quality Management System within a dynamic pharmaceutical environment. /ppReporting to the GDP QA Manager, the successful candidate will operate with a high degree of autonomy, taking ownership of key GDP Quality Assurance activities and making sound, risk-based decisions to ensure regulatory compliance and business continuity. /ppThis role is responsible for independently managing core quality processes, including deviations, change control, complaints, temperature excursion assessments. /ppThe successful candidate will be expected to proactively identify quality and compliance risks, drive continuous improvement initiatives, and exercise independent judgment in resolving complex quality issues while ensuring alignment with GDP requirements and internal stakeholders requests. /ppThis is an excellent opportunity for a quality professional with strong GDP expertise, excellent analytical and problem-solving skills, and a proven ability to work independently, prioritize competing demands, and make timely, risk-based decisions while maintaining the highest standards of product quality, regulatory compliance, and patient safety. /ph3You will be responsible for /h3ulliSupporting the definition, implementation, and continuous improvement of Quality Systems aligned with GDP requirements and industry best practices. /liliManaging, executing and/or supporting the following processes:ulliDeviations /liliCAPA /liliChange Control /liliAudits (internal, supplier, and customer) /liliDistribution Complaints /liliSupplier Qualification /liliCustomer/Wholesaler Bona Fide /liliQuality and Technical Agreements with Customers/Suppliers /liliShipping and transportation validation activities /li /ul /liliEnsuring proper record retention in accordance with GDP and internal standards. /liliParticipating in investigations and support the implementation and effectiveness check of Corrective Action Preventative Action. /liliEnsuring quality risk management documentation is complete and up to date. /liliManaging or support recall operations promptly /liliSupporting the evaluation and management of returned, rejected, recalled, or falsified products. /liliReviewing temperature excursions and support the suitability assessment for product release or rejection. /liliEnsuring customer complaints are handled efficiently and documented appropriately. /liliOverviewing subcontracted GDP‑impacting activities when delegated. /liliSupporting regulatory inspections and 3PL, customer audits. /liliPartecipating in the definition of Quality metrics (deviations, CAPA, Change Control, KPIs and others) /liliRepresenting the Quality GDP department during internal and external meetings when delegated. /liliPerforming Responsible Person responsibilities when required. /liliDeputizing for the GDP QA Manager as needed to ensure continuity of operations and compliance. /li /ulh3You will need to have /h3ulliQualification in a scientific or technical discipline and /or more than 8 years relevant industry experience /liliKnowledge of Quality standards and Regulatory guidelines and requirements relating to pharmaceutical and/or biotech products /liliDemonstrated skills and experience in the conduct of Quality activities as described above /liliExperience in project management, analytical, problem-solving /liliGood prioritization capability and comfortable adapting to meet changing priorities /liliAbility to manage urgent situations effectively and rapidly switch focus between multiple topics and priorities as business needs evolve /liliDemonstrated ability to work autonomously, exercise sound judgment, and make timely, risk-based decisions /liliExcellent interpersonal skills andcollaboration skills to optimise relationships with internal and external partners /li /ulh3We would prefer for you to have /h3ulliComfortable working in an environment where the QMS will expand and grow in support of company growth /liliStrong time management skills /liliWillingness to learn and continuously improve skills /liliExperience working with pharmaceutical products for rare diseases (orphan drugs) is considered a strong advantage /li /ulh3Location /h3pThe primary work location is Parma (Italy).

The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required. /ph3Compensation Range /h3pThe minimum salary for this role is € 46.000, aligned to our established salary framework.

The final offer will reflect the candidate’s skills, experience,qualificationsand internal equity considerations. /ppThis role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance. /ppIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. /ppThe package outlined above is based on the rolebeing located inItaly.

Where the role is offered in a different country, the applicable salary,bonusand benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at theappropriate stageof the recruitment process. /ph3What we offer /h3pNo 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. /ppWe 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. /ppChiesi 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. /p /p

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