John Kayati

About John Kayati

I am a Senior Quality Assurance Manager with recognized expertise in Quality Systems ensuring quality and regulatory concepts in a global pharmaceutical environment. I have proven abilities in Quality Control and Quality Assurance, employee relations, performance management, employee training and development, scheduling and planning. With a strong focus on process orientation, I have the ability to organize/ manage multiple priorities successfully, providing vision and leadership while demonstrating effectiveness in attaining results through others. Key skills include:• Experienced in Quality Systems, GMP, GLP, Audits and Inspections • Knowledge of ICH and FDA Regulations• Technical/Investigative writing & CAPA Management• Knowledge/experience in Pharmaceutical testing & Vaccine Manufacturing• Trained in Operational Excellence and People Management• Trouble shooting & problem solving skills• Proven determination for continuous improvement

Experience

1. Sr Director, Quality Assurance, Gmp Manufacturing

   GEMMA Biotherapeutics

   Oct 2024 — Present · Philadelphia, PA, US

   Key Responsibilities:• Responsible for leading the strategy and conduct of Quality Assurance services within GEMMABio. • Provide professional expertise and leadership in the Quality function as it relates to GMP QMS and Quality Strategy. • Ensures Quality Assurance activities are aligned with corporate goals. • Oversees Quality Assurance team providing guidance and direction ensuring client/project goals are met / coaches and develops team members. • Partners with internal and external clients to manage a best in class GxP Quality Assurance (QA) program which enhances the organization’s capabilities and continued growth. • Oversees/develops Quality Management System. • Participates in the development, implementation, and maintenance of clinical development and GEMMABio strategies; This includes but is not limited to leadership in the areas of quality, compliance, and operational excellence in all aspects of QA support to clinical trial operations (e.g, clinical, data management, clinical supplies, quality assurance, etc.). • Manages the GxP QA process and implements QA initiatives/audit programs which lead to continuous improvement. • Manages the corrective/preventive action plan (CAPA) process to ensure timely implementation of CAPAs, and escalation, as applicable. • Conducts GxP audits of company systems, in particular, non-clinical operation audits as needed and ensures appropriate follow-up. • Develops and leads audit / inspection readiness activities and appropriately addresses outcomes. • Audits CTL /CDMO organizations as required. • Writes reports on audit activities; supports responses to Regulatory Inspections and Sponsor audits of GEMMABio. • Oversees SOP development process and compliance. • Plays a major role in ensuring the stability of the operation while remaining adaptable to the changing needs of the new pre-clinical and clinical programs.

Education

• Rutgers University

  B.A, Biology

  1981 — 1986

• Paul VI High School, Haddonfield NJ

  Diploma, College prepatory - life sciences

  1977 — 1981

Skills

• Scheduling & Planning
• Quality Control
• Gmp
• U.s. Food and Drug Administration (Fda)
• Project Planning
• Laboratory Operations (Analytical Testing)
• Continuous Improvement
• Project Management
• Good Laboratory Practice (Glp)
• Capa
• Change Control
• Testing
• Glp
• Pharmaceutical Industry
• Sop
• Fda
• Process Scheduler
• Standard Operating Procedure (Sop)
• Raw Material (Receipt, Sampling, Dispensing, Testing)
• Validation
• Technical Writing/Deviation Management
• Quality Assurance
• Biopharmaceutical (Vaccine Manufacturing) Experience
• Environmental Monitoring
• Six Sigma
• Pharmaceutics
• Warehouse Management/Inventory Control
• Corrective and Preventive Action (Capa)
• Quality Control/Quality Assurnce
• Lean Manufacturing/Six Sigma Methodologies
• Quality Management Systems
• Quality System
• V&V
• Regulatory Compliance
• Biotechnology
• Laboratory
• Personnel Management/Leadership/Training
• 21 Cfr Part 11
• Data Analysis/Batch Record Review & Approval