This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. Job Description Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. Discover Impactful Work: You will join a new mRNA GMP facility in Monza and participate in the general compliance of the mRNA site by providing advice on strategies applicable to the innovative mRNA product, collaborating with our Customers, Quality, Supply Chain, Production, Finance, QC and Health Authority. You will be a key support to the mRNA business growth and being the quality services supervisor, in accordance with the mRNA Quality Head to ensure the compliance of the company to the quality regulations (laws, GMP, FDA, ATMP), through the management of the qualification of suppliers and their compliance with company policies and regulation, in charge of leading quality audit from customer and regulatory inspection (Health Authority), the negotiation of Quality Agreements with suppliers, the management of CAPA in compliance with procedures and company quality standards, the data integrity compliance activity and promote our service offering. What is a day in the Life? Corporate alignment about requirements for supplier management will be lead, with support in the implementation of an annual plan for external audits of suppliers. To oversee Quality Agreement negotiation with the supplier in compliance with current regulations (laws, European and international GMP standards and company standards). Ensure, in collaboration with the departments involved, the corrective/preventive actions, responsibilities and timing, to address "observations", non-compliance or "prescriptions" originating from: complaints to suppliers, external (client, regulatory) and internal audits. To ensure that the mRNA GMP activities are compliant with company quality standards, procedures, quality policies. Regulatory Knowledge & Expertise, Advance knowledge on Italian laws and regulatory environment, with regulatory support digest and disseminate information, assist in impact assessment and educate the mRNA team. Moreover, leading internal mRNA audits. To lead internal audits, from customer and regulatory entities, to allow ad hoc performance of the GMP activities, in compliance with current regulations (laws, GMP rules, CFR 21, etc.), customer specifications, business interests. You will be in charge of the compliance of the mRNA activity to Data Integrity. Manage the Quality Services team, coordination, propose the more efficient structure, development of team. Keys to Success: REQUIREMENTS AND QUALIFICATIONS: Degree in Chemistry, Pharmacy or Biology or diploma with proven experience, GMP regulations, Technical and computer skills: Office, Languages: English and Italian, Personality: Open, curious, Interpersonal Skills, Ready to educate and learn across teams. REPORTS: All business and External functions, Health Authorities, Suppliers, Customers during visits, Adaptable to a dynamic work environment, Agile interaction with interfaces, customers, health authority and other external partners, Customer-centric attitude with strong corporate driver, Ability to work with cross-functional teams and in a matrixed environment, Ability to prioritize workload to meet timelines. Adhere to OHS policies and procedures and ensure safe and healthy workplace environment. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status. Join us!
