Quality Systems Manager

Job Title: Quality Systems ManagerLocation: Exton, PAType: Contract, Potential for extension or conversion to permanentResponsibilitiesCollaborate 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 sites. Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for company's 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. RequirementsEducation and ExperienceBachelor’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) TechnicalStrong attention to detail as demonstrated through consistent quality of work Excellent written and verbal communication skills Computer proficiency in MS Word and Excel, Project and Visio required; Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output Strong project management skills are preferred Ability to anticipate potential problems and take proactive action to avoid/minimize impact Anticipates consequences of actions and how they impact other areas Ability to independently prioritize, plan and schedule workflow Timely follow up to ensure satisfactory resolution to issues Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately Ability to interpret and apply GMPs, relevant laws, guidance’s and directives to extremely complex pharmaceutical situations Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency Ability to work collaboratively with internal and external team members and customers/contacts Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance. Ability to work in a controlled environment Good attendance and reliability BenefitsSystem 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.