Director of CGMP Systems Delivery & Strategy

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 to lead the internal GMP delivery capability. You will define the operating model, standards, and commercial approach integrating design, fabrication, installation, qualification, and turnover for CGMP systems.

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