CGMP Systems Delivery Architect & Strategy Lead

Germfree; Ormond Beach (FL); In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Germfree seeks a Director, GMP Systems Delivery in Florida to lead the internal CGMP delivery capability, defining the operating model, standards, and commercial approach for CGMP projects.

You will manage third-party vendors, drive governance for CSV/CSA, and ensure compliance with 21 CFR Part 11 and ISO/GAMP guidance while guiding CQV and Field Service groups toward scalable, repeatable delivery.

Competenze

• Lead CGMP delivery capability and define operating model, standards, and commercial approach.
• Coordinate design, fabrication, installation, qualification, and turnover for CGMP systems.
• Manage third‑party vendors and govern CSV/CSA compliance per 21 CFR Part 11 and ISO/GAMP.

Mansioni

• Oversee vendor management and CGMP project delivery.
• Guide CQV and Field Service groups toward scalable, repeatable delivery.
• Ensure regulatory compliance across CGMP systems.

Conoscenze

GMP delivery

Vendor management

CSV/CSA governance

21 CFR Part 11

Descrizione del lavoro

Germfree seeks a Director, GMP Systems Delivery in Florida to lead the internal CGMP delivery capability, defining the operating model, standards, and commercial approach for CGMP projects.

You will manage third-party vendors, drive governance for CSV/CSA, and ensure compliance with 21 CFR Part 11 and ISO/GAMP guidance while guiding CQV and Field Service groups toward scalable, repeatable delivery.