What are the responsibilities and job description for the IT Quality systems manager position at Infotree Global Solutions?
Responsible for maintaining and improving Quality Systems to ensure compliance with applicable GMPs, compendia, and regulatory guidance for the Client’s Americas Region. Key responsibilities include quality risk management, documentation, auditing, training, event management, and change control. Acts as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements while collaborating with cross-functional teams.
Key Responsibilities:
- Ensure records, documents, and Quality Systems comply with GMP and DI requirements.
- Support internal and external audits and health authority inspections.
- Monitor and trend quality metrics for compliance oversight.
- Manage processes to ensure adherence to global quality policies and regulatory requirements.
- Collaborate with Quality personnel across Client sites and support ongoing quality initiatives.
Requirements:
- Bachelor’s degree (preferably in a science discipline).
- 5–7 years of experience in Quality Systems (e.g., Deviation, Change Control, CAPA).
- Proficiency in Quality Systems IT applications (e.g., TrackWise, Documentum).
- In-depth knowledge of CGMPs (EU, JP, US) and data integrity standards.
- Strong communication, attention to detail, and project management skills.
- Proficiency in MS Word, Excel, Project, and Visio.
- Experience in regulated pharmaceutical, biotech, or medical device environments.
Job Type: Contract
Pay: $75.00 - $88.00 per hour
Schedule:
- 8 hour shift
Experience:
- Quality systems: 7 years (Required)
- Pharmaceutical/biotech environment: 6 years (Required)
Ability to Commute:
- Exton, PA 19341 (Required)
Work Location: In person
Salary : $75 - $88
