Quality Systems Manager

Position – Contract Quality Systems ManagerLocation – Exton, PAContract – 12 Months with a possibility of extension Job Summary:Responsible for maintaining and improving Quality Systems to ensure compliance with GMP, Data Integrity (DI), and regulatory requirements across the Americas region. Acts as a subject matter expert (SME) and collaborates with cross-functional teams to support audits, inspections, and quality processes.Key Responsibilities:Ensure compliance of records, documents, and Quality Systems with GMP & DI standards.Support internal and external audits and inspections.Manage and monitor Quality Systems (deviations, CAPA, change control, complaints).Track and analyze quality metrics for continuous improvement.Maintain compliance with global quality policies and regulatory requirements.Collaborate with global Quality teams and stakeholders.Requirements:Bachelor’s degree (Science preferred).5–7 years of experience in Quality Systems (Deviation, CAPA, Change Control, Audits).Experience in pharmaceutical/biotech/medical device environment.Knowledge of CGMP (US/EU/JP) and Data Integrity.Hands-on experience with systems like TrackWise, Documentum.Strong communication, analytical, and project management skills.Kind Regards,Brian Joel Tech Observer 201-500-9403 www.tech-observer.com