Work Location: Chester County, Pennsylvania

Summary:

The Site Quality Lead (US) is responsible for overseeing the quality strategy, compliance, and performance at a US-based facility. This role provides leadership for all site quality activities, including quality operations, systems, document control, inspection readiness, licensing compliance, audits, and continuous improvement. The position ensures compliance with GxP, FDA, and state regulations, translating global quality strategies into local execution with a focus on patient safety, regulatory compliance, operational excellence, and customer satisfaction.

Responsibilities:

• Lead and direct all site quality functions, ensuring alignment with global quality objectives and regulatory requirements.
• Oversee quality systems, including deviation management, CAPA, change control, supplier quality, training compliance, and documentation control.
• Maintain inspection readiness and audit preparedness, serving as the primary quality representative during regulatory inspections and client audits.
• Ensure compliant product disposition, release activities, and support investigations, recalls, and product quality assessments.
• Monitor and implement evolving regulatory and state licensing requirements, ensuring ongoing compliance and readiness for new registrations.
• Partner with cross-functional leaders to support business growth, new client implementations, and expansion of operational capabilities.
• Lead, coach, and develop quality staff, fostering a high-performance culture and driving talent development and succession planning.
• Build and manage a collaborative team, ensuring clear objectives, effective communication, and recognition of individual and team achievements.

Qualifications:

• Degree in Life Sciences, Pharmacy, Chemistry, or a related scientific discipline highly preferred.
• Minimum 10 years of quality experience in pharmaceutical, biotechnology, clinical supplies, GMP, or GDP environments.
• At least 5 years of leadership experience.
• Experience supporting FDA inspections and customer audits.
• Proven ability to manage quality systems and quality operations functions.
• Strong knowledge of FDA 21 CFR requirements, cGMP, GDP, ICH Guidelines, risk management, validation, and clinical supply chain operations.
• Highly computer literate, with proficiency in Microsoft Office software.

Published Category: Quality & Validation