Affiliates Manager
Parma, IT
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
As an Affiliates Manager you will play a pivotal role in ensuring the highest standards of quality across our global operations. Your work will be closely aligned with the Global Technical Operations & Supply division, focusing on managing and enhancing quality systems in various affiliate locations. This role demands a proactive approach to quality management, where you will lead initiatives that support continuous improvement and compliance with regulatory requirements.
You will serve as a key liaison between affiliates and the central quality team, fostering collaboration to harmonize processes and standards globally. Your expertise will drive projects that not only uphold but also elevate our quality frameworks, ensuring our products meet the utmost standards of safety and efficacy.
You will engage with cross-functional teams to implement quality enhancements, contributing to a culture of excellence and integrity. This position offers the opportunity to influence quality strategies at a global level, supporting company growth while maintaining the highest compliance standards.
You will be responsible for
- Core member of the Quality Affiliates Transformation Project team, fully engaged in all related activities
- Active participant in the Affiliates Quality Council
- Data collection and co-leadership of the Regional Quality Council
- Support to Affiliates for:
- Definition, implementation, and continuous improvement of Local Quality Management Systems
- Standardization of local processes and alignment (included related SOPs) to Global Quality Standards
- Execution of local operations, with in particular a focus on oversight on local products/CMOs and 3PLs
- Onboarding colleagues in the Global projects and/or initiative, such as Veeva implementation
- Authorities’ inspection at Affiliates
- Definition of Quality organization and structure in case of new Affiliates
- Primary point of contact for affiliates on quality-related topics, such as change control and deviation management
- Drafting and discussion of Quality and Technical Agreements with Affiliates
You will need to have
- Qualification in a scientific or technical discipline and more than 8 years relevant industry experience
- Knowledge of Quality standards, Regulatory guidelines and requirements related to pharmaceutical and/or biotech products
- Demonstrated skills and experience in conducting Quality activities as described above including system implementation, audits, compliance monitoring, and regulatory inspections
- Strong analytical skills with the ability to interpret complex quality data and regulatory requirements to inform effective decision-making
- Proficiency in managing quality documentation and processes, with a strong orientation to detail and accuracy
We would prefer for you to have
- A highly motivated and proactive mindset, with excellent organizational and project management skills to effectively manage multiple priorities
- Strong analytical and problem-solving capabilities, enabling prompt identification of issues and implementation of robust corrective actions
- Excellent prioritisation skills, with the ability to adapt to evolving business and regulatory environments
- Exceptional interpersonal skills, fostering productive collaboration with diverse teams and stakeholders across global locations
- Demonstrated ability to work cohesively within cross-functional teams, leveraging collective expertise to achieve shared quality objectives
- Proficiency in negotiation and conflict resolution, facilitating positive outcomes and maintaining constructive relationships
- Strong active listening skills, with a commitment to responsiveness and timely support of colleagues' needs
- Cultural sensitivity and the ability to engage effectively with individuals from a variety of backgrounds and regions
- Resilience and flexibility, with readiness to adapt and manage change in dynamic business environments
- Strong time management skills, balancing proactive planning with responsiveness to unexpected priorities
- A genuine willingness to continuously learn and enhance professional skills, embracing ongoing development opportunities
Location
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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