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.
PDS business unit at Monza site is looking for a Quality Operations Leader.
Main scope of the PDS Quality Manager / QP:
Ensure that Quality Operations meets cGMP and regulatory compliance with respect for the defined methods, current regulations, and corporate quality standards. Promote accurate and proactive business partnership with site functions and facilitate people and organization development.
Tasks:
Product Quality
Lead the reporting structure (Quality On The Floor staff and Quality Operations staff ) ensuring the proper review of production manufacturing and documentation, CoAs and possible investigations in full compliance with cGMPs, registration documentation and clients requirements
Support the Qualified Person in product disposition and issues assessment
Ensure respect for the corporate quality standards through auditing and overseeing the application of the procedures relative to the area managed.
Guarantee the surveillance of on-shift production activities (overlooking and fit&finish in production area), to pro-actively increasing the Quality Culture within the Departments.
Operations
Ensure support to site operations to meet cGMP requirements and Corporate Standards
Facilitate optimal interactions with clients to ensure the respect of Quality Agreements and to develop business
Support operations performance review to identify potential deficiencies and risks, recommend solutions for quality performance issues (e.g. related to RFT and OTD), promote action plans and improvement initiatives ensuring an accurate follow up
Compliance
Support the activities of gap analyses versus the GMP regulations updating and new guidelines requests; contribute to the related plan elaboration, including the definition and the monitoring of the accurate corrective actions to ensure GMP site compliance.
Support the site Regulatory Inspections in order to assure that each inspection is properly and effectively managed
Budget
Support the Supervisor in the preparation of the budget for the function, ensuring supply of the required data and the budget proposal for the area of responsibility, respecting the corporate standards.
Management of organization
Manage performance and development of collaborators to ensure achievement of personal and site goals as well as a "great place to work" environment
Ensure the direction, coordination and control of the organization managed through the definition of objectives, valuing of the results, analysis of needs for training and development in order to guarantee a high level of performance and motivation.
Personnel management
Guarantee that both the initial and the continuous training of the department personnel are performed and is suited to the needs.
The ideal candidate shows leadership skills, ability to manage complex projects, to prioritize.
Expertise in pharmaceutical companies, exposure to clients and regulatory matters is crucial.
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.
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