Quality & Compliance System Senior Specialist

Quality & Compliance System Senior SpecialistBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards . We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors . Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Global Manufacturing Division Chiesi Group has three production plants: Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced. In 2024, a new Biotech Centre of Excellence has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins. Blois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs. Santana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI). In 2025, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products. Who we are looking for Main Responsibilities Developing and Implementing Quality Management Systems (QMS): this includes creating and updating procedures, processes, and documentation to meet quality standards. Monitoring and Analyzing Quality Data:Tracking quality metrics, identifying trends, and pinpointing areas for improvement. Preparing and submitting periodic reports on the performance of the quality management system to company management. Conducting Audits and Inspections:Ensuring compliance with established quality systems through regular audits and inspections of processes and products. Planning, coordinating, and conducting internal and external audits to verify compliance with GMP, ISO, and corporate regulatory requirements. Ensuring that any non-conformities identified are resolved promptly. Defining and monitoring the implementation of corrective and preventive actions (CAPA) following audits with periodic follow-ups. Maintaining and updating audit documentation, including self-audit plans and reports. Preparating pre-inspection documentation and site GMP documentation required for inspection and regulatory purposes Working with Cross-Functional Teams: collaborating with other departments (e.g., production, engineering, procurement) to resolve quality issues and improve processes. Investigating Quality Issues: analyzing root causes of quality problems and developing corrective and preventative action plans. Experience Required At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sector, specifically in Quality Assurance, Production, and Process Technology departments. Education Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering). Languages Fluent English (both written and spoken). Technical Skills Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations). Ability to establish strategies for managing multiple projects efficiently and effectively. Specialized expertise in GMP compliance improvement processes. Strong teamworking skills, contributing positively and constructively to achieving goals. Capacity to analyze technical issues and find shared solutions, evaluating related risks. Soft Skills Problem solving Planning and organizational skills What we offer You would join a dynamic, fast-growing, challenging and friendly environment.In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being. We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services. #J-18808-Ljbffr