Senior Director – Head of Quality / Quality Site Head

Hiring: Senior Director – Head of Quality / Quality Site Head

Location: Houston, TX, USA
Work Arrangement: Onsite

Position Overview

We are seeking an experienced Quality Site Head to provide strategic leadership and management of the site's Quality organization. The ideal candidate will have extensive experience in commercial manufacturing, Quality Assurance (QA), Quality Control (QC), and GMP compliance.

Key Responsibilities

• Lead the site's Quality organization and provide strategic direction.
• Develop and execute quality strategies aligned with business objectives.
• Ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
• Oversee Quality Assurance, Quality Control, and continuous improvement initiatives.
• Lead regulatory inspections, customer audits, and corrective action programs.
• Evaluate and enhance existing quality systems and processes.
• Develop training and professional development plans for quality teams.
• Build strong relationships with customers, regulatory authorities, and internal stakeholders.
• Drive quality transformation, operational excellence, and process improvements.
• Provide quality and compliance guidance to cross-functional teams.

Key Requirements

• Strong experience in commercial manufacturing.
• Proven leadership experience in QA and QC within a GMP environment.
• Deep knowledge of GxP, ISO standards, FDA regulations, and quality compliance.
• Experience leading quality transformation and continuous improvement initiatives.
• Proven track record in compliance remediation and quality turnaround projects.
• Experience managing budgets and strategic quality programs.
• Ability to lead and develop teams within complex organizations.
• Excellent communication, negotiation, problem-solving, and stakeholder management skills.
• Strong decision-making abilities and a results-oriented approach.