Contract Quality Systems Manager at Hired by Matrix

Pay Rate: 59.28-62.85 $/Hour

• Responsible for maintaining and improving Quality Systems for Americas Region to ensure on-going compliance to applicable compendia, GMP’s, and Regulatory guidance.
• Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local).
• Interface with Quality System personnel on other sites.
• Serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements.
• Must effectively work as a team with internal customers, peers, and management through effective oral and written communication.
• Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and Data Integrity requirements.
• Essential Functions:
  • 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 Americas sites.
  • Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for Americas sites.
  • Develop and manage processes that ensure site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.
  • Other duties as assigned to facilitate ongoing Quality activities as required, including collaboration with other Quality groups. 

• Bachelor’s degree (preferably in science related discipline) preferred.
• 5 to 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).
• 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.
• Anticipates consequences of actions and how they impact other areas.
• 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:
  • Anticipate potential problems and take proactive action to avoid/minimize impact.
  • Work in a controlled environment.
  • Independently prioritize, plan and schedule workflow
  • Interpret and apply GMPs, relevant laws, guidance’s and directives to extremely complex pharmaceutical situations.
  • Work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.
  • 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.
• Good attendance and reliability.