Stephan Gambon

About Stephan Gambon

Accomplished Technical Manager consistently recognized for Microbiology, Analytical Chemistry and Validation expertise. Leader of cross-functional teams driving operational improvements. Established Quality System policies to comply with US FDA and international regulations for Class implantable medical devices and human tissue allografts.Validation and Laboratory Management • Responsible for Microbiology, Analytical Chemistry, and Quality Engineering laboratories/departments. Managed 73 staff members and $7.5 million annual budget. • Established Validation Program procedures and practices. Responsible for corporate project Validation Planning. • Managed process, equipment, software, sterilization validation planning and execution. • Managed test method development and validation, sample tracking, and laboratory Out of Specification investigations. • Ensured laboratory support for operational needs across multiple shifts, 24/7/365.cGXP/ISO Compliance (21 CFR 820, 21 CFR 1271, 21 CFR Part 11, and ISO 13485) • Established and maintained policies and practices for Quality System. • On-site Audit Facilitator and Subject Matter Expert for US FDA, Notified Body, Australian TGA, Korea FDA, and 3rd party audits/assessments. • Core team lead for remediation efforts associated with audit observations/483 items. • Fifteen years Supplier Quality Auditing – abattoirs, chemicals, packaging materials, lab services, and contract manufacturers.• American Association of Tissue Banks (AATB) Committee member drafting Process Validation and Microbiological Controls Guidance and Packaging Validation GuidanceBusiness Development • Core team member for Due Diligence efforts evaluating acquisition operational and compliance opportunities and challenges. • Coordinated with partners in China and Brazil to ensure technology and procedural compliance. • Member of internal Patent Review Team.

Experience

1. Senior Director, Mfg Technical Support & Validation

   Werfen North America

   Mar 2023 — Present · US

   Responsible for the Validation function at three USA manufacturing sites. Additionally responsible for a team of Investigators performing Root Cause Investigations focused on Atlanta site product in-process Deviations and Valid Out of Specification Investigations as well as final product complaint investigations. Identification and management of appropriate CAPA responses to Root Cause Investigations.

Education

• Bates College

  Bachelor of Science (BS), Biology, General

  1989 — 1993

Skills

• Testing
• Fda
• Biotechnology
• Capa
• Validation
• Quality Control
• Gmp
• Quality System
• Quality Assurance
• Pharmaceutical Industry
• Iso 13485
• Team Building
• Glp
• Cross-Functional Team Leadership
• Sop
• Medical Devices
• Corrective and Preventive Action (Capa)
• Standard Operating Procedure (Sop)
• Good Laboratory Practice (Glp)