Quality Systems Manager

Job Title: Quality Systems Manager

Location: Exton, PA

Type: Contract, Potential for extension or conversion to permanent

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 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.

Requirements

Education and Experience

• 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)

Technical

• Strong 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

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.