Global Operational Compliance Lead

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its headquarters 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.

At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose, fostering 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 Parnaíba (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. In 2025, a new investment at Nerviano (Italy) will construct a new facility primarily dedicated to manufacturing carbon‑minimal inhalers, dry powder inhalers and sterile biological products.

Operational Compliance and Continuous Improvement Lead

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 in driving continuous improvement initiatives. The position is based in Parma, Italy, and reports to the Global Operational Compliance Head.

Responsibilities

• Cooperate with site quality representatives to ensure the consistent quality of products manufactured across Chiesi Farmaceutici SPA sites, respect and monitor Quality KPIs, support the application of quality governance processes and manage main global quality operation‑related topics, including handling non‑conformities, deviations, and change control.
• Support the cascade of guidelines and internal global SOPs, providing implementation support at local level.
• Guarantee compliance of validation processes and collaborate on drafting Validation Project Plans and Validation Final Reports for major internal projects.
• Collaborate closely with Quality Directors at each site to address common challenges such as business continuity assessments, corporate audits, and inspections from authorities.
• Align quality processes and contribute to the Quality Council and governance processes at local and global levels (Tier 1 and Tier 2).
• Work alongside Compliance teams to ensure quality standards meet internal and regulatory requirements.
• Drive a culture of quality excellence throughout the organization.

Qualifications

• 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.
• Demonstrated leadership and influence across cross‑functional teams across multiple sites; experience in change management and governance framework development.
• Excellent communication skills: outstanding relationship‑building and 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 such as Microsoft Project to plan, execute, and monitor quality‑related projects.
• Familiarity with software such as 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.

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