Global Operational Compliance Lead

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 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. This is what you will do Within the Global Quality Operations department , we are seeking an Operational Compliance and Continuous improvement Lead to support and coordinate global activities and processes related to quality operations management of internal and external production including analytical processes. This role is pivotal in ensuring that a harmonized quality approach can be applied and driving continuous improvement initiatives. The role is based in Parma Italy, with a line report to the Global Operational Compliance Head. You’ll be responsible for: Integrated Quality operations Management: Cooperate with site quality representatives to ensure the consistent quality of products manufactured across our Chiesi Farmaceutici SPA sites, to respect and monitor the Quality KPI’s, to support the application of quality Governance process and to manage the main Global quality operation-related topics within the group, including the handling of potential non-conformities, deviations and change control. Support to cascade guidelines and internal global SOPs providing support to the implementation at local level Cooperate to guarantee compliance of the Validation processes and collaborate on the drafting of Validation Project Plans and Validation Final Reports of the main internal projects. Cross-Site Support: Collaborate closely with the Quality Directors representatives at each site to address common challenges (i.e. business continuity assessments, Corporate Audits, Inspection from Authorities). Support to align quality processes and contribute to the Quality Council and governance process at Local and Global Level (Tier1 and Tier 2) Collaboration with Compliance: Work alongside the Compliance teams to support the process ensuring that quality standards meet internal and regulatory requirements. Strategic Leadership: Provide support to the process to drive a culture of quality excellence throughout the organization. You will need to have Minimum of 10 years of experience in pharmaceutical quality assurance, with at least 5 years in a role with a proven track record in quality operations. Deep understanding of quality management systems, compliance standards, and regulatory requirements within the pharmaceutical sector. Leadership capabilties: Demonstrated ability to lead, influence, and collaborate with cross-functional teams across multiple sites. Experience in change management and governance framework development. Excellent Communication skills: Outstanding relationship-building skills, with the capacity to communicate complex quality issues clearly to various stakeholders. Strategic Thinking: Ability to analyze processes, foresee challenges, and implement effective solutions that enhance overall quality performance English fluency (spoken & written) IT Skills Proficient in Microsoft applications including Excel, Word, Powerpoint, Outlook and Teams Ability to use project management tools like Microsoft Project to plan, execute, and monitor quality-related projects. Familiarity with software like TrackWise, or Veeva QualityDocs for managing quality documentation and processes 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.