Rod Abdali

About Rod Abdali

Experienced Senior Production Manager with a demonstrated history of working in the biotechnology industry. Skilled in Software Documentation, U.S. Food and Drug Administration (FDA), Validation, Quality Assurance, and Manufacturing. Strong operations professional with a Masters of Public Administration (MPA) focused in Health science, Environmental science from San Jose State University.

Experience

1. Sr Imp Clinical Product Technical Manager, Qa

   Genentech

   Sep 2014 — Present · South San Francisco, CA, US

   Perform lot disposition, business process owner for IMP, SSF for large molecules, cell banking, drug substance/API, drug product, and finish goods.• Serve as the Lead Quality Liaison for small molecule programs, providing authoritative oversight across development, manufacturing, and regulatory functions to ensure total GxP compliance and audit readiness.• Provide leadership and technical support in the development and implementation of GMP clinical quality systems supporting clinical production.• Implement and maintained all pharmaceutical quality system PQS within the department of quality assurance.• Review and approve local and global quality procedures, and policies in collaboration with cross functional groups.• Act as department representation on project teams and manage cross-functional initiatives. • Manage interface with quality compliance, audit team, to support audit, due diligence, and inspection readiness plans. • Administered internal audits and provide support for external inspections. • Develop new and improved processes in collaboration with other QMS elements, Stewarts and global leadership. • Provide quality systems support for all products, including electromechanical, biomedical, and medicines. • Coordinate with plants, R&D, RA, and labeling and other internal supervisors, functional peers and senior leaders, and lead interactions with regulators and customers to represent the company products and processes. • Identify and direct improvement project, to achieve quality, reliability, and cost improvements.• Ensure that products are dispositioned in accordance with regulatory requirements, cGMP, and company standards.

Education

• San José State University

  Masters of Public Administration (MPA), Health science, Environmental science

  2004 — 2008

Skills

• Biotechnology
• Technology Transfer
• Quality Control
• Gmp
• Lean Manufacturing
• Continuous Improvement
• Life Sciences
• Quality System
• Process Simulation
• Pharmaceutical Industry
• Sop
• Fda
• Gcp
• Biopharmaceuticals
• Capa
• Validation
• Quality Auditing
• Aseptic Processing
• Software Documentation
• Regulatory Submissions
• Cross-Functional Team Leadership
• Change Control
• Manufacturing
• Lifesciences
• Quality Assurance