Head of Quality Systems & GxP Compliance

Scorpion Therapeutics

California (MO)

Hybrid

USD 180,000 - 260,000

Full time

11 days ago
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Job summary

Scorpion Therapeutics is seeking a senior leader to head our Quality Systems, overseeing document control, training, and ongoing GxP compliance. This role ensures cGMP alignment across the organization and supports regulatory readiness.

You will act as the Business Process Owner of QMS, mentor teams, and drive cross-functional quality initiatives while monitoring metrics and guiding system updates to sustain top-tier quality performance.

Qualifications

  • Bachelor's in life sciences with 12+ years in biopharma.
  • 7+ years leading Quality Systems.
  • 5+ years of people management.
  • Expertise in QMS processes: CAPA, Change Control, Deviations, Risk Management.
  • Veeva Vault experience preferred.

Responsibilities

  • Lead and oversee Quality Systems including document control and GxP training.
  • Ensure compliance with cGMP and regulatory standards.
  • Act as Business Process Owner of QMS and manage cross-functional quality projects.
  • Oversee FDA, EMA, ICH, and GxP compliance and support inspections.
  • Drive continuous improvement, monitor performance metrics, and implement system updates.

Skills

QMS leadership
GxP compliance
Regulatory knowledge
People management
Quality systems

Education

Bachelor's in life sciences

Tools

Veeva Vault

Job description

Scorpion Therapeutics is seeking a senior leader to head our Quality Systems, overseeing document control, training, and ongoing GxP compliance. This role ensures cGMP alignment across the organization and supports regulatory readiness.

You will act as the Business Process Owner of QMS, mentor teams, and drive cross-functional quality initiatives while monitoring metrics and guiding system updates to sustain top-tier quality performance.

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