Quality Operations Manager, Clinigen, PA, US

About Quality Operations at 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 Quality Operations Manager is accountable for ensuring that all operations within the Quality team at CSM USA are executed in full compliance with GxP regulations, Clinigen Quality Systems, and industry standards.

This role provides leadership across quality activities, representing the department on project teams to drive a consistent and controlled approach to quality actions in alignment with global expectations.

To be successful in this role you should have:

• Bachelor’s degree in a scientific or related field.
• 6+ years of experience in Quality within the pharmaceutical, biotechnology, or clinical supply industries.
• 3+ years of supervisory or management experience.
• Strong knowledge of GxP, ICH guidelines, and EU GMP/EU GDP regulations.

Your role at Clinigen:

• Lead the implementation and integration of a robust Quality Management System (QMS) in compliance with GxP regulations and guidelines.
• Oversee Quality Assurance Operations and Systems, ensuring current GxP (Good Manufacturing/Good Distribution/Good Clinical Practice) compliance across site activities.
• Develop and maintain a Quality Risk Management framework in line with ICH Q9.
• Manage the Quality Batch Release process, ensuring compliance with regulatory and company standards.
• Oversee product recall operations and collaborate with Marketing Authorization Holders and Competent Authorities as required.
• Ensure appropriate qualification and validation of facilities, equipment, processes, and computerized systems.
• Work cross-functionally with business areas to drive operational excellence and customer satisfaction.
• Lead site quality review meetings and escalate key issues to senior management when required.
• Engage directly with clients to strengthen relationships, resolve quality-related issues, and identify opportunities for improvement.
• Ensure business continuity through effective back-up planning and cross-training of staff.

We’re excited about you if you have:

• Proven ability to develop, implement, and enforce Standard Operating Procedures (SOPs).
• Strong leadership, team-building, organizational, communication and time management skills.
• 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.