Director, CGMP Delivery & Validation Systems

Evolving Solution Services; Ormond Beach (FL); On-site; USD 180,000 - 240,000; Full time

Job summary

Germfree seeks a Director of GMP Systems Delivery to build and lead its internal CGMP delivery capability, linking design, fabrication, installation, qualification, and turnover into a single offering for CGMP customers.

You will guide strategy with CQV and Field Service, ensure data integrity and regulatory alignment, and manage vendor relationships while driving financial performance and client commitments.

Qualifications

• Bachelor’s degree in engineering or related technical field required.
• Minimum 12 years in GMP facility, equipment, or process delivery in pharma/biotech.
• Minimum 5 years leading multidisciplinary technical teams.

Responsibilities

• Build Germfree’s internal GMP delivery capability and operating model.
• Own strategy for CGMP systems delivery across design, procurement, fabrication, installation, qualification, turnover.
• Collaborate with CQV and Field Service to align strategy and resources across offerings.
• Provide governance for data integrity, including 21 CFR Part 11 and EU GMP Annex 11.
• Manage third-party vendors for automation, controls, and process engineering.

Skills

GMP delivery

CQV

CSV/CSA

Vendor management

GxP compliance

Project leadership

Regulatory strategy

Cross-functional collaboration

Education

B.S. in engineering

MBA (preferred)

Tools

Microsoft Office (Outlook, Word, Excel, SharePoint, OneDrive)

Job description

Germfree seeks a Director of GMP Systems Delivery to build and lead its internal CGMP delivery capability, linking design, fabrication, installation, qualification, and turnover into a single offering for CGMP customers.

You will guide strategy with CQV and Field Service, ensure data integrity and regulatory alignment, and manage vendor relationships while driving financial performance and client commitments.