Quality Systems Specialist

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Requirements:

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries.
• 1+ years of experience in manufacturing, operations, or related business areas.
• Demonstrated experience in process ownership and quality systems management.
• Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines.
• Experience with electronic quality management systems, specifically Veeva.

Responsibilities:

• Serve as global process support for Deviation, CAPA, Change Control, Regulatory Intelligence, and Training processes.
• Facilitate analysis of Quality Systems metrics and performance periodically.
• Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures.
• Oversee Regulatory Intelligence assessments and maintain associated documentation.
• Facilitate the Change Control Review Board and maintain associated documentation.
• Partner with subject matter experts to identify GxP training content needs and modify curricula.
• Support development of Quality related training content.
• Support quality systems audits and regulatory inspections.
• Provide guidance and support to site quality teams in process implementation.