Senior Quality Assurance Gdp Specialist

Chiesi; Parma; In loco; EUR 41.000 - 51.000; Tempo pieno

Descrizione del lavoro

Chiesi is seeking a Senior GDP QA Specialist to strengthen the GDP Quality Management System in a dynamic pharmaceutical environment. You will own core GDP QA activities, autonomously manage deviations, CAPA, change control, audits, and temperature excursions, and support regulatory inspections while aligning with GDP requirements.

The candidate should have a scientific/technical qualification with 8+ years of experience, strong analytical and problem-solving skills, and the ability to work

Competenze

• Qualification in a scientific or technical discipline and/or 8+ years of relevant industry experience.
• Knowledge of quality standards and regulatory guidelines for pharma/biotech products.
• Demonstrated skills in quality activities as described above.
• Experience in project management, analytical and problem solving.
• Good prioritisation and ability to adapt to changing priorities.
• Ability to work autonomously and make timely, risk-based decisions.
• Excellent interpersonal and collaboration skills.

Mansioni

• Manage deviations, CAPA, Change Control, audits (internal, supplier, customer), distribution complaints, supplier qualification, customer/supplier quality agreements, shipping and transportation validation, and record retention.
• Participate in investigations and support effectiveness checks of CAPA.
• Ensure quality risk management documentation is complete and up to date.
• Manage or support recall operations promptly.
• Support evaluation/management of returned, rejected, recalled, or falsified products.
• Review temperature excursions and assess release decisions.
• Ensure customer complaints are handled efficiently and documented.
• Oversee subcontracted GDP-impacting activities when delegated.
• Support regulatory inspections and 3PL/customer audits.
• Define quality metrics and participate in internal/external meetings.
• Represent the GDP QA department as needed and deputize for GDP QA Manager.

Conoscenze

Quality standards

Regulatory guidelines

Quality activities

Project management

Analytical skills

Problem solving

Prioritization

Autonomous work

Interpersonal skills

Formazione

Scientific or technical discipline

Descrizione del lavoro

Senior Quality Assurance GDP Specialist Chiesi Vicofertile, Emilia‑Romagna, Italy

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.

Global Technical Operations & Supply

Global Technical Operations & Supply (Global TechOp&S) 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 TechOp&S 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.

This is what you will do

We 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. Reporting 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. This role is responsible for independently managing core quality processes, including deviations, change control, complaints, temperature excursion assessments. The 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. This 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, prioritise competing demands, and make timely, risk‑based decisions while maintaining the highest standards of product quality, regulatory compliance, and patient safety.

Key Responsibilities

• Managing, executing and/or supporting the following processes: Deviations, CAPA, Change Control, Audits (internal, supplier, and customer), Distribution Complaints, Supplier Qualification, Customer/Wholesaler Bona Fide, Quality and Technical Agreements with Customers/Suppliers, Shipping and transportation validation activities, Ensuring proper record retention in accordance with GDP and internal standards.
• Participating in investigations and support the implementation and effectiveness check of Corrective Action Preventative Action.
• Ensuring quality risk management documentation is complete and up to date.
• Managing or support recall operations promptly.
• Supporting the evaluation and management of returned, rejected, recalled, or falsified products.
• Reviewing temperature excursions and support the suitability assessment for product release or rejection.
• Ensuring customer complaints are handled efficiently and documented appropriately.
• Overseeing subcontracted GDP‑impacting activities when delegated.
• Supporting regulatory inspections and 3PL, customer audits.
• Participating in the definition of Quality metrics (deviations, CAPA, Change Control, KPIs and others).
• Representing the Quality GDP department during internal and external meetings when delegated.
• Performing Responsible Person responsibilities when required.
• Deputizing for the GDP QA Manager as needed to ensure continuity of operations and compliance.

Qualifications

• Qualification in a scientific or technical discipline and /or more than 8 years relevant industry experience.
• Knowledge of Quality standards and Regulatory guidelines and requirements relating to pharmaceutical and/or biotech products.
• Demonstrated skills and experience in the conduct of Quality activities as described above.
• Experience in project management, analytical, problem‑solving.
• Good prioritisation capability and comfortable adapting to meet changing priorities.
• Ability to manage urgent situations effectively and rapidly switch focus between multiple topics and priorities as business needs evolve.
• Demonstrated ability to work autonomously, exercise sound judgment, and make timely, risk‑based decisions.
• Excellent interpersonal skills and collaboration skills to optimise relationships with internal and external partners.

Desirable Skills

• Comfortable working in an environment where the QMS will expand and grow in support of company growth.
• Strong time management skills.
• Willingness to learn and continuously improve skills.
• Experience working with pharmaceutical products for rare diseases (orphan drugs) is considered a strong advantage.

Location

The primary work location is Parma (Italy). The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required.

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. The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process.

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.

Equal opportunity

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.