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 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.
 

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.