Site Quality Lead

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

About Clinigen:

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world. The Site Quality Lead is accountable for the overall Quality strategy, compliance, and performance of the USA facility. The role will translate global Quality strategy into local execution while maintaining a strong focus on the patient safety, regulatory compliance, operational excellence, and customer satisfaction.

To be successful in this role you should have:

Degree in Life Sciences, Pharmacy, Chemistry, or related scientific discipline highly preferred Minimum 10 years' Quality experience in pharmaceutical, biotechnology, clinical supplies, GMP or GDP environments Minimum 5 years leadership experience Experience supporting FDA inspections and customer audits Experience managing Quality Systems and Quality Operations functions Knowledge in FDA 21 CFR requirements, cGMP, GDP, ICH Guidelines, Risk Management, Validation, and Clinical Supply Chain operations.

Your role at Clinigen :

• 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, applicable GxP requirements, and state licensing obligations.
• Develop and execute the site Quality strategy aligned with global Quality objectives.
• Maintain overall 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.

We're excited about you if you have:

• Experience in leading, coaching and developing Quality staff.
• Ability to drive talent development and succession planning.
• Proven ability to develop, implement, and enforce Standard Operating Procedures (SOPs).
• Demonstrated 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.
• Familiarity with Quality by Design and risk-based approaches to quality management.
• High level of integrity and confidentiality in handling proprietary and client information.

While at Clinigen, you'll enjoy:

• The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague's Clinigen experience can be a bit different, and we're proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
• The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We've been able to take steps to continuously improve how we do things at Clinigen.
• The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

EEO.

Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.