Director, GMP Systems Delivery

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Full Time Director Ormond Beach, FL, US

6 days ago Requisition

Job Title:Director, GMP Systems Delivery

Reports to:Chief Strategy & Services Officer

Location:Remote, with travel to Germfree HQ and Client Site

Work Schedule:5 days/week; extended hours, weekends, and off-hours client coverage may be required at times.

Travel Requirements:Willingness and ability to travel up to 35% of the time, domestic and international, to project sites and client locations.

Job Overview:At Germfree, you will be recognized as a leading expert in an environment that values grit, integrity, ownership, and innovation—principles that lie at the core of our culture. We are committed to engineering and developing cutting‑edge solutions that create a tangible impact in the real world.

As the Director, GMP Systems Delivery, you will build and lead Germfree’s internal GMP delivery capability, providing a suite of services to CGMP-regulated customers. You will own the overall strategy for how Germfree delivers CGMP systems — the operating model, standards, and commercial approach that connect design, fabrication, installation, qualification, and turnover into a single offering — working closely with the CQV and Field Service groups, who own their respective operations.

You will also own the selection and technical management of the third‑party vendors who deliver automation, controls, and process engineering scope — holding their work to Germfree standards rather than accepting it as delivered.

You bring deep, practical command of how GMP facilities, equipment, and computerized systems are designed, qualified, and validated, and you are equally comfortable arbitrating a hard engineering decision, defending a validation package to a client’s quality group, and holding a vendor or project team to schedule, scope, and margin. Because our equipment supports high‑impact environments such as clean rooms.

This is a builder’s role before it is a manager’s role. Germfree has established CQV, Field Service, and Certification teams as well as in‑house design and build capabilities. This role will integrate all of these offerings into a comprehensive package tailored for our CGMP customers. Those teams and their leaders remain in place, continuing to own their own operations; the objective is to give them a stronger operating model, clearer standards, and the resources to take on larger and more complex GMP scope.

Key Responsibilities:

• Build Germfree’s internal GMP delivery capability: define the service lines, operating model, organizational design, rate structure, utilization targets, and the gating criteria for each phase of hiring.
• Own the overall strategy for delivery of CGMP systems, ensuring design, procurement, fabrication, installation, qualification, and turnover connect as one repeatable offering for regulated customers rather than as separate handoffs.
• Work closely with the CQV and Field Service groups, aligning strategy, standards, resourcing, and client commitments across the combined offering while each group continues to run its own operations.
• Establish Germfree’s approach to computer system validation and computer software assurance (CSV/CSA), providing a risk‑based, critical‑thinking framework for assuring GxP computerized systems consistent with current FDA guidance and GAMP 5 (Second Edition), in coordination with the CQV group.
• Provide governance for data integrity across validated systems, including 21 CFR Part 11 and EU GMP Annex 11 compliance, ALCOA+ principles, audit trail review, and electronic records and signatures.
• Select,…