Senior Director Quality Engineering

Our client is building its next-generation Quality Engineering function and seeking a Senior Director, Quality Engineering to lead that transformation. This newly created, enterprise-level role combines validation leadership with AI-driven innovation — perfect for a forward-thinking technical leader ready to redefine what quality looks like in modern pharma. This is an on-site position in Houston TX.

Key Responsibilities

• Oversee enterprise validation programs (equipment, process, and CSV).
• Build and expand the Quality Engineering organization, including R&D Quality and NPI/Tech Transfer support.
• Drive integration of AI and statistical analytics into quality systems and lifecycle management.
• Partner cross-functionally with operations, R&D, and digital teams to elevate quality performance.

Ideal Profile

• Deep technical foundation in validation and quality systems within pharma, biotech, or life sciences.
• Experience leveraging AI, data science, or advanced analytics in quality or validation settings.
• Strong leadership skills; able to architect and scale a new function from the ground up.
• Strategic thinker passionate about digital transformation and continuous improvement.

Seniority Level

Director

Employment Type

Full-time

Job Function

Engineering, Management, and Manufacturing

Industries

Pharmaceutical Manufacturing and Medical Equipment Manufacturing