Manager - Quality Management Systems

Catalent Pharma Solutions

Madison, Wisconsin, United States
Not specified; not specified; generous 401k match;...
100% on-site
Fda and regulatory compliance
Deviation and capa management
Change control program ownership
Catalent Pharma Solutions is seeking a Manager for Quality Management Systems at their Madison, Wisconsin location. The ideal candidate will have a strong background in quality assurance within the pharmaceutical or biopharmaceutical industry, with leadership experience and a focus on regulatory compliance

Job Summary

  • The role provides oversight to ensure Quality Systems are maintained in compliance with FDA and other regulatory agency requirements.
  • Candidates will be accountable for the Investigation and CAPA Management Systems and the Change Control Program while managing complex deviations.
  • Catalent offers a diverse, inclusive culture with potential for career growth on an expanding team dedicated to preserving lives.

Matching Summary

Match Score: 85

Catalent Pharma Solutions is seeking a Manager for Quality Management Systems at their Madison, Wisconsin location. The ideal candidate will have a strong background in quality assurance within the pharmaceutical or biopharmaceutical industry, with leadership experience and a focus on regulatory compliance.

Salary

Not specified; Not specified; Generous 401K match; 152 hours PTO + 8 paid holidays; Medical, dental, vision effective day one; Tuition Reimbursement

Skills & Requirements

Must-have

  • FDA and regulatory compliance
  • Deviation and CAPA management
  • Change Control Program ownership
  • TrackWise Subject Matter Expert
  • Cross-functional team leadership

Nice-to-have

  • Process improvement initiatives
  • Metrics development and reporting
  • Innovative culture participation
  • Dynamic pace environment

Key Requirements

  • Doctorate in STEM with 4 years experience
  • Master's in STEM with 7 years experience
  • Bachelor's in STEM with 9 years experience
  • Minimum 4 years leadership experience

Work Rights

Not specified

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