Head Of Global Operational Compliance

Chiesi; Parma; Hybrid; EUR 73,000 - 100,000; Full time

Benefits offered by this job

Company car

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Job summary

Chiesi is seeking an accomplished quality assurance leader for its Global Technical Operations & Supply. The role focuses on overseeing product quality across sites, guiding validation activities, and ensuring compliance with EMA, FDA, and other authorities. Fluent English and extensive QA leadership experience are essential.

The primary work location is Parma, Italy, with hybrid flexibility. The role offers an annual bonus, company car, pension, private medical insurance, and a

Qualifications

• Degree in scientific disciplines is required.
• Minimum 15 years in pharmaceutical quality assurance with at least 10 years in a leadership role.
• Deep understanding of quality management systems, compliance standards, and regulatory requirements.

Responsibilities

• Oversee and ensure consistent product quality across sites, manage quality topics and non-conformities.
• Establish guidelines for validation of systems and processes per GMP regulations.
• Supervise validation processes and draft Validation Plans and Final Reports with timelines and corrective actions.
• Collaborate with Quality Directors to address audits, business continuity, and regulatory inspections; align quality processes.
• Provide leadership to drive a culture of quality excellence and coordinate Quality Council activities.

Skills

Quality Assurance Leadership

Regulatory Compliance

Quality Management Systems

GMP Knowledge

English Fluency

Education

Degree in scientific disciplines

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.

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

• Support to oversee and ensure the consistent quality of products manufactured across our Chiesi Farmaceutici SPA sites, to respect the Quality KPIs and to manage all Global quality-related topics within the group, including the handling of potential non-conformities, deviations and change control.
• Support to establishes guidelines for the validation of systems and processes according to national and international GMP regulations.
• Supervise to guarantee the compliance of the Validation processes and collaborate on the drafting of Validation Project Plans and Validation Final Reports. Set goals and timelines, evaluate data, and coordinate corrective actions.
• Collaborate closely with the Quality Directors at each site to address common challenges (i.e. business continuity assessments, corporate audits, inspection from authorities). Support to align quality process and to coordinate the Quality Council at Local and Global Level (Tier 1 and Tier 2).
• Work alongside the Compliance teams to ensure that quality standards meet internal and regulatory requirements. Provide strong leadership and guidance to drive a culture of quality excellence throughout the organization.

Requirements

You will need to have a degree in scientific disciplines, a minimum of 15 years of experience in pharmaceutical quality assurance, with at least 10 years in a leadership role with a proven track record in quality operations and management. Deep understanding of quality management systems, compliance standards, and regulatory requirements within the pharmaceutical sector. Experience with EU, US and rest of the World authorities (EMA, FDA). Fluency in English (Spoken and written).

Preferred

Strong leadership: Demonstrated ability to lead, influence, and collaborate with cross-functional teams across multiple sites. Experience in change management and governance framework development. Excellent communication: Outstanding relationship-building skills, with the capacity to communicate complex quality issues clearly to various stakeholders. Strategic thinker: Ability to analyze processes, foresee challenges, and implement effective solutions that enhance overall quality performance.

Location

The primary work location is Parma (Italy). The role offers flexibility, combining on-site presence with remote work.

Budgeted Salary Range

The budgeted salary range approved for this role is between 73.000 and 100.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position.

Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, 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 company car, pension, private medical insurance, wellbeing programme, flexible benefits programme.

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.

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