Quality Control Operations & Compliance Manager

Catalent

Kansas City (MO)

On-site

USD 120,000 - 150,000

Full time

4 days ago
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Benefits offered by this job

Competitive PTO
8 paid holidays
Medical, dental and vision benefits

Job summary

Catalent’s Kansas City facility is seeking a Manager, Quality Control Support Services to provide strategic and operational leadership for Stability, Sample Management, and electronic systems within the QC department. You will oversee teams, allocate resources, and ensure data integrity while supporting audits and regulatory inspections.

The role requires strong supervisory experience, deep cGMP knowledge, and a track record of continuous improvement.

Qualifications

  • Bachelor's degree in a life science or physical science field with 7+ years of pharma/quality experience, or a Master’s with 5+ years and prior supervision.
  • Strong knowledge of cGMP requirements and data integrity principles.
  • Experience leading and developing multiple teams and coordinating resources across Stability, Sample Management, and electronic systems.
  • Ability to manage audits, inspections, and regulatory interactions with clear communication.

Responsibilities

  • Lead Stability, LIMS/master data, and Sample Management teams including second shift; set priorities and monitor performance.
  • Oversee sample lifecycle from receipt to disposition and destruction.
  • Provide after-hours stability chamber support and issue resolution.
  • Maintain GLIMS and Track-IT system compliance and inspection readiness.
  • Ensure cGMP compliance and client commitments across activities.
  • Develop and revise SOPs and controlled documents.
  • Oversee capital expenditures, change controls, deviations, and investigations.
  • Drive continuous improvement through team coaching and project leadership.
  • Serve as escalation point for technical/compliance issues and audits.
  • Assist in DEA clearance and controlled substance inventory verification.

Skills

Leadership
Project management
Quality systems
Data integrity
Regulatory compliance
Problem solving
Team development

Education

Bachelor's degree in life science or physical science
Master's degree in related field

Tools

LIMS
GLIMS
Track-IT

Job description

Catalent’s Kansas City facility is seeking a Manager, Quality Control Support Services to provide strategic and operational leadership for Stability, Sample Management, and electronic systems within the QC department. You will oversee teams, allocate resources, and ensure data integrity while supporting audits and regulatory inspections.

The role requires strong supervisory experience, deep cGMP knowledge, and a track record of continuous improvement.

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