Associate Quality Manager
Eva NYC
Quality Operations Manager
Clinigen
full-time
Posted on:
Origin: • 🇺🇸 United States • Pennsylvania
Visit company websiteJob 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.
