Andy Stribling

Experience

1. Vice President, Quality and Regulatory

   Mikart, LLC

   Jun 2019 — Present · Atlanta, GA, US

   Manage QA, QC, and Regulatory Departments, including budgets, recruitment, and training. • Evaluate the functional strengths in the Quality organization and focuses on continuous improvement.• Set department goals and performance objectives. This includes directing team of senior managers and professionals within Quality and Regulatory in support of company objectives. • Evaluate capital expenditures necessary to maintain or improve departmental operations. • Interface with regulatory officials (FDA, DEA, etc.) during plant audits.• Maintain relations with customers to aid in compliance with applicable regulations and support release of product. • Resolve quality and regulatory issues associated with the manufacturing, testing and use of products.

Education

• Auburn University

  B.S., Wildlife Science

  1989 — 1994

• Missouri State University

  M.S., Biology

  1994 — 1996

Skills

• Pharmaceutical Industry
• Quality Assurance
• Gmp
• Analytical Chemistry
• Drug Development
• Fda
• Validation
• Medical Devices
• Quality System
• Regulatory Affairs
• Cross-Functional Team Leadership
• Oncology
• Sop
• Lifesciences
• Capa
• Change Control
• Glp
• Pharmaceutics
• Product Launch
• Biotechnology
• Regulatory Submissions
• 21 Cfr Part 11
• Biopharmaceuticals
• Technology Transfer
• Chemistry
• Vendor Management
• Compliance
• Quality Systems
• Cgxp Practices
• Management
• Life Sciences
• Good Laboratory Practice (Glp)
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• Corrective and Preventive Action (Capa)
• U.s. Title 21 Cfr Part 11 Regulation