Site Quality Lead

Clinigen • Malvern, PA

6h

About The Position

The Site Quality Lead is accountable for the overall Quality strategy, compliance, and performance of Clinigen’s USA facility. The role translates global Quality strategy into local execution, with a focus on patient safety, regulatory compliance, operational excellence, and customer satisfaction. The Site Quality Lead serves as the senior Quality representative for the US facility and provides leadership and oversight for all Quality functions and activities, including Quality Systems and Quality Operations.

The role is responsible for regulatory and state compliance, ongoing compliance with FDA and applicable GxP requirements, and state licensing obligations. It develops and executes the site Quality strategy in alignment with global objectives and maintains accountability for inspection readiness and audit preparedness. The Site Quality Lead also acts as the management representative for site Quality matters and leads Quality Management Review activities and site Quality governance forums.

The position supports US business growth initiatives by providing Quality leadership for new client implementations and helping expand service offerings and operational capabilities. It also involves leading, coaching, and developing Quality staff, supporting talent development and succession planning, and handling proprietary and client information with integrity and confidentiality.

Requirements

• Minimum 10 years of Quality experience in pharmaceutical, biotechnology, clinical supplies, GMP, or GDP environments.
• Minimum 5 years of leadership experience.
• Experience supporting FDA inspections and customer audits.
• Experience managing Quality Systems and Quality Operations functions.
• Knowledge of FDA 21 CFR requirements, cGMP, GDP, ICH Guidelines, risk management, validation, and clinical supply chain operations.
• Ability to drive talent development and succession planning.
• Proven ability to develop, implement, and enforce Standard Operating Procedures (SOPs).
• Ability to manage multiple projects, solve problems, and make sound decisions in a fast-paced environment.
• Experience supporting global audits and regulatory inspections.
• Knowledge of clinical supplies processes and supply chain operations.
• High level of integrity and confidentiality in handling proprietary and client information.

Nice To Haves

• Degree in Life Sciences, Pharmacy, Chemistry, or a related scientific discipline is highly preferred.
• Familiarity with Quality by Design and risk-based approaches to quality management.

Responsibilities

• Serve as the senior Quality representative for the US facility.
• Provide leadership for all Quality functions and activities.
• Oversee Quality Systems and Quality Operations.
• Ensure regulatory and state compliance, including FDA, applicable GxP requirements, and state licensing obligations.
• Develop and execute the site Quality strategy aligned with global Quality objectives.
• Maintain accountability for inspection readiness and audit preparedness.
• Serve as management representative for site Quality matters.
• Lead Quality Management Review activities and site Quality governance forums.
• Support US business growth initiatives.
• Provide Quality leadership for new client implementations.
• Support expansion of service offerings and operational capabilities.
• Lead, coach, and develop Quality staff, including talent development and succession planning.
• Develop, implement, and enforce Standard Operating Procedures (SOPs).

Benefits

• Competitive benefit offering and programs that celebrate success.
• Inclusive company culture with opportunities for engagement and involvement.
• Weekly opportunity to share anonymous feedback with leadership through the employee engagement platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior