Site Quality Head

Site Head of Quality

📍 Location: On-site (Long Island, NY) | 💼 Full-time | 🏭 Manufacturing Environment

Overview

We are partnering with a global life sciences manufacturing organisation to appoint a Site Head of Quality. This is a critical leadership role responsible for shaping and driving the quality strategy across a high-performing, regulated manufacturing site.

This opportunity is ideal for an experienced Quality Manager, Senior Manager, or Director looking to step into (or further develop within) a site-level leadership position, with full ownership of Quality Assurance, Quality Control, and Quality Engineering.

You will play a pivotal role in ensuring compliance, strengthening quality culture, and enabling operational excellence in a highly regulated environment.

The Opportunity

As Site Head of Quality, you will:

• Lead and develop site-wide Quality functions (QA, QC, Quality Engineering & Laboratories)
• Act as the site's Quality Management Representative, ensuring an effective and compliant QMS
• Drive regulatory compliance (FDA, cGMP, ISO 9001 / ISO 13485) and maintain audit readiness
• Partner with cross-functional teams (Manufacturing, Supply Chain, Regulatory) to deliver right-first-time quality performance
• Own quality systems including CAPA, deviations, change control, validation, complaints, and risk management
• Lead regulatory inspections and internal audits, ensuring strong outcomes and continuous improvement
• Implement and enhance a robust Quality Management System (QMS) aligned with global standards
• Embed a culture of continuous improvement, operational excellence, and quality ownership across the site

Key Responsibilities

Quality Leadership & Strategy

• Define and execute the site quality strategy aligned to global business and regulatory expectations
• Provide visible leadership to the Quality organisation, fostering accountability and engagement
• Act as the primary quality interface with senior leadership, regulators, and customers

Compliance & QMS

• Ensure full compliance with FDA, EPA, cGMP, ISO 9001 / ISO 13485 and CFR requirements
• Maintain and continuously improve the site QMS, ensuring effectiveness and scalability
• Oversee inspection readiness and audit programmes, with responsibility for remediation

Operational Quality Excellence

• Drive performance across deviation, CAPA, complaint handling, validation, and risk management processes
• Monitor and analyse quality metrics, identifying trends and implementing improvements
• Support manufacturing in delivering consistent, compliant product supply

Team Leadership

• Lead, coach, and develop multidisciplinary quality teams
• Build a high-performing organisation with strong succession planning and capability growth

About You

We are seeking a hands-on, strategic quality leader with:

• A Bachelor's degree in Science, Engineering, or related discipline (or equivalent experience)
• 7+ years' experience in Quality, Manufacturing, or Quality Engineering within:
• Pharmaceuticals
• Biotechnology / Biopharma
• Medical Devices
• Other regulated manufacturing environments
• Strong knowledge of:
• ISO 9001 / ISO 13485
• FDA regulations / cGMP / CFR requirements
• Core quality systems (CAPA, validation, audits, risk management)
• Proven experience in leading teams and influencing cross-functional stakeholders
• A track record of improving quality systems, compliance, and operational performance

Why Apply?

• High-impact leadership role with full site quality ownership
• Opportunity to influence strategy, culture, and performance at scale
• Join a globally recognised organisation with strong investment in quality and innovation
• Competitive salary, benefits, and long-term career progression

Apply

If you are a Quality leader ready to take the next step into a site-level role or expand your leadership impact, we would welcome a confidential discussion.