Joe Fotso

Experience

1. Senior Manager, Operations Quality Assurance

   Pfizer

   Sep 2015 — Present · Lake Forest, IL, US

   Provide strategic QA support for large molecules (e.g, Nyvepria (biosimilars)), small molecules (e.g, Emblaveo®, Paxlovid), sterile injectables, and medical device & combination products (MDCP)(e.g, Nyvepria) across multiple international internal and external manufacturing sites, diverse quality functions and activities. • Ensured compliance with technology transfer and global regulatory/compendial requirements (ICH, USP, USFDA, EMA, TGA, PMDA, ANVISA, EP, JP, etc.).• Collaborate with suppliers to ensure products/services meet Pfizer technical and compliance expectations. • Successfully led development and implementation of internal quality agreements between the R&D organization and dozens of commercial manufacturing sites for manufacture of investigational APIs and drug products. • Contribute to qualification and/or transition of suppliers to Commercial Quality.• Developed an end-to-end interactive vendor management process to harmonize understanding and enhance efficiencies.• Initiated and approved change control forms prior to implementation of changes. • Qualified raw materials, ensuring alignment of CoAs with approved specifications, ICH, USP, TGA, PMDA, ANVISA, EP, JP, and other applicable compendial or regulatory requirements.• Collaborate with global manufacturing sites Quality Units to ensure successful process development and transfer.• Oversaw investigations to completion: Probable or root causes, CAPAs, and ECs.• Supported successful regulatory submissions. • Developed and implemented of the Quality Regulatory Intelligence process in R&D Quality (team formation, process flow, impact assessments, internal cross-site/cross-functional communications, meeting coordination, and archiving of key documentation).• Initiated and led the Digital Quality Agreement (QA) Templates initiative to simplify and harmonize the process and reduce the turn-around time for generation of QAs.• Coached and developed newly hired staff/colleagues.

Education

• Kansas State University

  Doctor of Philosophy (Ph.D.)

• University of Yaounde I

  Doctorate

Skills

• Fda
• Biotechnology
• Pharmaceutical Industry
• Lifesciences
• Lc-Ms
• Hplc
• Capa
• Validation
• Technology Transfer
• Analytical Chemistry
• Gmp
• Laboratory
• Microbiology
• Chromatography
• Formulation
• R&D
• Biochemistry
• Quality System
• Chemistry