Quality Systems Leader: GxP, CAPA & Change Control

Scorpion Therapeutics; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager of Quality Systems to lead and optimize GxP quality management processes in a virtual biopharma setting. The role ensures FDA/ICH/EU compliance and supports inspection readiness.

You will oversee deviations, investigations, CAPA, change control, and quality metrics, leveraging electronic QMS platforms (Veeva preferred) and data analysis tools like Power BI. Collaboration across Quality, Regulatory, Clinical, and supply is essential.

Qualifications

• 5–10+ years in Quality Assurance or GxP compliance in pharma/biotech.
• Experience with electronic QMS (Veeva preferred).
• Proficiency in data analysis tools (Power BI).

Responsibilities

• Oversee deviations, investigations, CAPA, change control and quality metrics.
• Manage electronic QMS platforms (Veeva preferred).
• Provide risk-based guidance and drive continuous improvement across Quality, Regulatory, Clinical and supply functions.
• Develop SOPs and training materials; analyze quality metrics.
• Support vendor oversight and system implementations; audit preparations.

Job description

Scorpion Therapeutics is seeking a Senior Manager of Quality Systems to lead and optimize GxP quality management processes in a virtual biopharma setting. The role ensures FDA/ICH/EU compliance and supports inspection readiness.

You will oversee deviations, investigations, CAPA, change control, and quality metrics, leveraging electronic QMS platforms (Veeva preferred) and data analysis tools like Power BI. Collaboration across Quality, Regulatory, Clinical, and supply is essential.