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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