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.
FAQs
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