Director of Quality Engineering

About

Metric Bio are partnering with a pioneering Oral Solid Dose (OSD) CDMO to appoint a Director of Quality Engineering.

Location

Onsite, Oregon - the company offers an exceptional relocation support package.

Role Overview

This is a high-impact leadership role where you’ll shape and lead a modern, risk-based validation and CSA function across both clinical and commercial GMP operations. You’ll take ownership of end-to-end validation lifecycle strategy, ensuring facilities, utilities, equipment, processes, and computerized systems remain in a validated and inspection-ready state, aligned with FDA, EU, cGMP, and data integrity expectations.

A big part of the role is program leadership — driving and evolving:

• Validation Master Planning (VMP) and lifecycle management
• Commissioning, Qualification & Validation (CQV) programs across manufacturing and utilities
• Computer System Assurance (CSA) / CSV frameworks, including MES, LIMS, QMS, and ERP systems
• Data integrity and governance initiatives (ALCOA++) across GxP systems
• Risk-based validation approaches aligned with GAMP and modern regulatory expectations

You’ll also play a key role in modernising validation practices, introducing digital and risk-based approaches, and supporting automation and technology-driven manufacturing environments.

Working cross-functionally with Engineering, Manufacturing, QC, IT, and Regulatory, you’ll act as a critical Quality partner, while also serving as a key SME during regulatory inspections and client audits.

If you bring strong leadership experience and deep expertise across validation, CSA, and data integrity programs, and are looking to make a visible impact in a growing CDMO — let’s connect.