Site Director
W3Global · San Diego, CA · 1 mo ago
ManagementFull-time
Strategic Leadership
Spearhead the operations and regulatory requirements of a high-volume peptide compounding facility.
Compliance Integration
Implement and maintain robust cGMP and USP standards.
Production Oversight
Manage end-to-end manufacturing and sterile fill-finish for a dedicated peptide portfolio.
Quality Management
Manage the execution of Quality Management Systems (QMS), including CAPA, deviations, and change control.
Facility Scale-up
Oversee site readiness for rigorous federal and state regulatory inspections, including FDA and 503B.
Requirements
- Track Record: Minimum 5+ years of leadership specifically within a 503A or 503B Outsourcing Facility (absolute requirement).
- Technical Expertise: Deep knowledge of aseptic processing and sterile injectable requirements.
- Quality Credentials: Proven history of leading sites through successful Board of Pharmacy and FDA inspections.
- Education: B.S. in Pharmacy, Chemistry, or Life Sciences; advanced degree (PharmD/MBA) preferred.
- Leadership: Ability to build and mentor a high-performing technical team in a fast-paced environment.
- Background: Engineering background is a plus.
- Bilingual: Chinese or Mandarin