Clinigen

Quality Operations Manager

Clinigen

full-time

Posted on:

Location: Pennsylvania • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • Accountable for ensuring all Quality team operations at CSM USA comply with GxP regulations, Clinigen Quality Systems, and industry standards.
  • Provide leadership across quality activities and represent the department on project teams to drive consistent, controlled quality actions aligned with global expectations.
  • 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 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 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.

Requirements

  • 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.
  • 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.