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

1. Release of finished goods produced at Lema site and all imported CH and PH products for mexican market

2. Responsible for the overall Quality System at the site( including but not limited to change management, deviation management, Complaints, validation,etc.)

3. Responsible for regulatory support to LATAM countries receiving goods from Lerma site

4. Managing 7 departments therefore 3 QA Dpt. , 3 QC labs and one Quality Planning Dpt.

5. responsible for Audits performed by authorities at the site

6. 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.

Join Us: If you are a dedicated professional with a passion for quality assurance and a commitment to excellence in the pharmaceutical industry, we invite you to apply for the Head of Quality Unit position at Bayer de Mexico. Your expertise will contribute significantly to our mission of delivering high-quality products and ensuring compliance with the highest standards.

 

 

  Período de aplicación:08 al 22 de JulioCódigo de referencia:849951   División:Consumer Health  Ubicación:Mexico : Estado de Mexico : Toluca   Área funcional:Calidad  Grado de posición:VS 3   Tipo de empleo:Permanente Tiempo de trabajo:Full Time