Position – Contract Quality Systems Manager

Location – Exton, PA

Contract – 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