Senior Manager, Quality Systems

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

Job Title

Senior Manager of Quality Systems responsible for overseeing and improving GxP Quality Management System processes within a virtual biopharma setting.

Primary Objectives

Primary objectives include ensuring compliance with FDA, ICH, EU/EMA regulations, and supporting inspection readiness.

Responsibilities

Responsibilities encompass managing deviations, investigations, CAPA, change control, quality metrics, and electronic QMS platforms (preferably Veeva).

Cross-Functional Collaboration

The role involves cross-functional collaboration across Quality, Regulatory, Clinical, and supply functions, providing subject matter expertise, risk-based guidance, and driving continuous improvement.

Key Tasks

Key tasks include overseeing quality record lifecycle activities, developing SOPs and training materials, analyzing quality metrics, identifying systemic risks, and supporting vendor oversight.

Additional Duties

The position also entails supporting system implementations, audit preparations, and mentoring staff.

Qualifications

Qualifications: 5–10+ years in Quality Assurance or GxP compliance within pharma/biotech, with deep knowledge of regulatory requirements, experience with electronic QMS (Veeva preferred), and proficiency in data analysis tools (e.g., Power BI).

Communication Skills

Strong communication and stakeholder management skills are essential.

Education

The ideal candidate holds a Bachelor’s degree in a scientific discipline, with an advanced degree preferred.

Additional Requirements

This role demands hands-on expertise in quality systems, process optimization, and working in outsourced or lean environments, supporting a pipeline of innovative B-cell therapies.

Reporting & Location

The position reports to Quality leadership and is based in the United States, requiring minimal travel.