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Contract Quality Systems Manager

1 month ago

Exton, Pennsylvania, United States LanceSoft Full time
Job Summary

This is a challenging role that requires a strong background in quality systems and a proven track record of ensuring compliance with regulatory requirements. The successful candidate will be responsible for maintaining and improving quality systems for the Americas region, ensuring ongoing compliance with applicable compendia, GMPs, and regulatory guidance.

Key Responsibilities
  • Collaborate with quality system personnel in other sites to ensure consistency and compliance with regulatory requirements.
  • Develop and manage processes to ensure the Exton site remains in compliance with global quality policies, regulatory requirements, and industry standards.
  • Support external and internal audits for the Americas sites, ensuring that all quality systems are in place and functioning correctly.
  • Contribute to the oversight of quality systems core responsibilities, including tracking, reporting, and adjusting quality metrics for Americas sites.
Requirements
  • Bachelor's degree in a science-related discipline preferred.
  • 7 years of experience working with quality systems, including deviation, change control, CAPA, audit, and other related processes.
  • Demonstrated proficiency and experience in working with quality systems IT applications.
  • Training within a regulated pharmaceutical, biotech, or medical device environment.
  • Understanding and application of CGMPs (EU, JP, US).
  • Detailed knowledge and application of electronic quality systems (i.e. TrackWise, Documentum).
Technical Skills
  • Strong attention to detail and excellent written and verbal communication skills.
  • Computer proficiency in MS Word and Excel, Project and Visio required.
  • Demonstrates process orientation and 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 and able to work with minimal supervision. Exercises independent judgment in evaluating compliance.
  • Ability to work in a controlled environment.
  • Good attendance and reliability.