Director, Quality Systems

Scorpion Therapeutics; California (MO); Hybrid; USD 180,000 - 260,000; Full time

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

Role

Lead and oversee the company's Quality Systems, including document control and GxP training, ensuring compliance with cGMP and regulatory standards.

Responsibilities

Develop strategic roadmaps, manage and mentor teams, act as Business Process Owner of QMS, oversee compliance with FDA, EMA, ICH, and GxP requirements, and support inspection readiness. Drive continuous improvement, implement system updates, monitor performance metrics, and lead cross-functional quality projects.

Qualifications

Bachelor's in life sciences with 12+ years in biopharma, including 7+ years leading Quality Systems; 5+ years of people management; expertise in QMS (CAPA, Change Control, Deviations, Risk Management), with Veeva Vault experience preferred.

High-Value

extensive GxP experience, leadership in regulated biopharma environments, strategic planning, and global/regional compliance.

Work Setup

not specified; likely hybrid/on-site given senior leadership nature.