Head Of Quality

hace 3 días


estado de méxico Bayer A tiempo completo

Head of Quality Location: Lerma Site, Bayer de Mexico Position Purpose The Head of the Quality Unit at the Lerma site is a pivotal leadership position responsible for ensuring the integrity and compliance of the Quality System with all relevant regulations. This role encompasses the management of three Quality Assurance (QA) departments and the oversight of testing and release processes for all raw materials, packaging materials, and finished goods produced at the Lerma site, as well as imported Consumer Health (CH) and Pharmaceuticals (PH) products. As the designated \"Qualified person,\" this position is accountable for ensuring the market release of products in alignment with the standards set forth by the Mexican Health Authority, COFEPRIS. Major Tasks Release of finished goods produced at Lerma site and all imported CH and PH products for Mexican market Responsible for the overall Quality System at the site (including but not limited to change management, deviation management, complaints, validation, etc.) Responsible for regulatory support to LATAM countries receiving goods from Lerma site Managing 7 departments, therefore 3 QA departments, 3 QC labs and one Quality Planning Department Responsible for audits performed by authorities at the site Main contact of Lerma site to the global Q-functions and other CH PS sites Work Relations External: Engages with COFEPRIS and related Mexican authorities, external laboratories, and health authorities such as the FDA, NSF, ANVISA, INVIMA and others. Skills Chemical pharmacist with over 15 years of experience in the pharmaceutical industry. Exceptional communication skills, both verbal and written. Proficient in English, with the ability to engage with diverse stakeholders. Strong leadership capabilities, adept at managing a diverse department of approximately 100 FTEs. Comprehensive knowledge of Good Manufacturing Practices (GMP) and a thorough understanding of Mexican GMP requirements. Application Period 08 al 22 de Julio Division Consumer Health Location Mexico : Estado de Mexico : Toluca Functional Area Calidad Job Grade VS 3 Employment Type Permanente Work Hours Full Time #J-18808-Ljbffr



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