Remote CGMP Systems Delivery Director

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

Descrizione del lavoro

Germfree seeks a Director, GMP Systems Delivery to lead the creation of an internal GMP delivery capability and the strategy for CGMP systems. You will oversee design, procurement, fabrication, installation, qualification, and turnover, while managing third‑party vendors and CQV/Field Service partners to ensure compliant, scalable delivery.

You will drive policy, standards, and governance for CSV/CSA and data integrity, aligning with FDA guidance and GAMP 5, to support CGMP customers and

Mansioni

• Define and build Germfree’s internal GMP delivery capability and operating model.
• Own the overall CGMP delivery strategy across design, procurement, fabrication, installation, qualification and turnover.
• Collaborate with CQV and Field Service groups to align strategy, standards, and resources.
• Establish a risk-based framework for CSV/CSA in line with FDA guidance and GAMP 5.
• Provide governance for data integrity, 21 CFR Part 11, and EU GMP Annex 11 compliance.

Conoscenze

GMP Systems Delivery

CQV coordination

Vendor management

CSV/CSA

GxP compliance

Project leadership

Descrizione del lavoro

Germfree seeks a Director, GMP Systems Delivery to lead the creation of an internal GMP delivery capability and the strategy for CGMP systems. You will oversee design, procurement, fabrication, installation, qualification, and turnover, while managing third‑party vendors and CQV/Field Service partners to ensure compliant, scalable delivery.

You will drive policy, standards, and governance for CSV/CSA and data integrity, aligning with FDA guidance and GAMP 5, to support CGMP customers and