Found Description
Overview
Founding Director, Quality, Regulatory Affairs & Compliance | Portugal | Relocation package available
Join Spanance as a founding leadership team member and build the Quality, Regulatory, and Compliance function for a next-generation sterile pharmaceutical manufacturing facility.
Responsibilities
- Lead the establishment of the Quality, Regulatory Affairs & Compliance function for a greenfield sterile manufacturing facility.
- Provide direct exposure to executive leadership, investors, customers, and global regulatory authorities.
- Support site startup, licensing, and audit readiness programs, and coordinate regulatory inspections as needed.
Qualifications
- 15+ years in Quality, Regulatory Affairs, or Compliance within pharma, biotech, or CDMO environments
- Deep expertise in sterile manufacturing, aseptic processing, injectables, biologics, and GMP compliance
- Proven experience s...