What are the responsibilities and job description for the Quality Systems Manager position at System One?
Job Title: Quality Systems Manager
Work Schedule: Hybrid
Location: Exton, PA
Type: Contract
Overview
Leading pharmaceutical company looking for an experienced Quality Systems Manager. Ideal candidates should have 5-7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
Responsibilities
Requirements
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Work Schedule: Hybrid
Location: Exton, PA
Type: Contract
Overview
Leading pharmaceutical company looking for an experienced Quality Systems Manager. Ideal candidates should have 5-7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
Responsibilities
- Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
- Support external and internal audits for the company’s Americas sites.
- Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for company’s Americas sites.
- Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
Requirements
- Bachelor’s degree (preferably in science related discipline) preferred
- 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
- Demonstrated proficiency and experience in working with Quality Systems IT applications
- Training within a regulated Pharmaceutical/biotech/medical device environment
- Understanding and application of CGMP’s (EU, JP, US)
- Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum)
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
