Manager Quality Systems

Securelink Inc

Maryland Heights, MO, United States
On-site
Develop and maintain efficient quality systems
Ensure compliance with agency guidelines
Manage data integrity program
Develop, establish and maintain efficient quality systems, ensuring that performance conform to established standards and agency guidelines and to drive alignment and continuous improvement across regional sites

Job Summary

  • Develop, establish and maintain efficient quality systems, ensuring that performance conform to established standards and agency guidelines and to drive alignment and continuous improvement across regional sites.
  • Manage and oversee aspects of the Quality Management System (QMS) including but not limited to investigations, CAPA, change control, internal audit, training, and stability program.
  • By coaching and developing their team to High Performance, will foster a team ownership culture that ensures compliance with all Corporate and Local policies, procedures and regulations.

Matching Summary

Develop, establish and maintain efficient quality systems, ensuring that performance conform to established standards and agency guidelines and to drive alignment and continuous improvement across regional sites.

Skills & Requirements

Must-have

  • Develop and maintain efficient quality systems
  • Ensure compliance with agency guidelines
  • Manage Data Integrity Program
  • Oversee QMS aspects (investigations, CAPA, change control)
  • Ensure ALARA for direct reports
  • Collaborate with cross-functional groups

Nice-to-have

  • Foster a team ownership culture
  • Recognize and reward performance
  • Diplomatically challenge established procedures
  • Lean / Kaizen / Six Sigma experience
  • Experience with High Performance Teams

Key Requirements

  • Bachelor Degree in Life Science
  • 12+ years of Quality pharma experience
  • 2+ years in a leadership role
  • Expert knowledge of cGMP requirements
  • Prior experience managing regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter