Senior Site Quality Leader - FDA Readiness & Compliance

Clinigen Group; Malvern (Chester County); On-site; USD 140,000 - 190,000; Full time

Job summary

Clinigen Group is seeking a Site Quality Lead for the US facility. You will translate global Quality strategy into local execution, ensuring patient safety and regulatory compliance while supporting growth and new client implementations.

The role requires extensive leadership in Quality Systems, Operations, and audits, with strong experience in FDA inspections and risk-based quality management. A robust QA culture and audit readiness are essential.

Qualifications

• Degree in Life Sciences, Pharmacy, Chemistry, or related scientific discipline highly preferred.
• Minimum 10 years' Quality experience in pharma, biotech, GMP/GDP environments.
• Minimum 5 years leadership experience with FDA inspections and audits.

Responsibilities

• Serve as the senior Quality representative for the US facility.
• Provide leadership for all Quality functions and activities.
• Quality Systems and Quality Operations oversight.
• Responsible for regulatory and state compliance.
• Ensure ongoing compliance with FDA, GxP requirements, and state licensing obligations.
• Develop and execute the site Quality strategy aligned with global Quality objectives.
• Maintain audit readiness and lead Quality governance forums.
• Support US business growth initiatives and new client implementations.
• Support expansion of service offerings and operational capabilities.

Skills

Quality leadership

Quality systems

GxP compliance

FDA inspections

Risk management

Clinical supply chain

Staff development

Regulatory audits

SOP development

Education

Life Sciences degree

Pharmacy degree

Chemistry degree

Job description

Clinigen Group is seeking a Site Quality Lead for the US facility. You will translate global Quality strategy into local execution, ensuring patient safety and regulatory compliance while supporting growth and new client implementations.

The role requires extensive leadership in Quality Systems, Operations, and audits, with strong experience in FDA inspections and risk-based quality management. A robust QA culture and audit readiness are essential.