Sr. Mgr., Quality Management Systems

Scorpion Therapeutics; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Manager, Quality Management Systems to lead the QRM program and ensure GxP compliance across the organization. The role involves cross-functional risk assessments, process improvement, and supporting digital quality systems in a biotech setting.

You will back- up Document Control and GxP Training, maintain inspection-ready documents, and assist with audit prep across GMP, Clinical, CMC, and Regulatory functions.

Qualifications

• Bachelor's degree in a scientific or technical field.
• 7+ years in Quality Assurance within biotech/pharma.
• Proven expertise building and deploying QRM programs in GxP environments.
• Hands-on experience with validation of GxP computerized systems and risk-based lifecycle approaches.

Responsibilities

• Lead development and continuous improvement of QRM procedures and facilitate cross-functional risk assessments (e.g., FMEA).
• Ensure risk mitigation actions are tracked and addressed.
• Serve as backup for Document Control and GxP Training.
• Maintain inspection-ready documentation, support audit preparations, and collaborate across GMP, Clinical, CMC, and Regulatory functions; support digital quality systems and risk-based validation of GxP computerized systems.

Skills

Quality Assurance

GxP knowledge

Risk Management

QRM

Veeva Vault Quality

Education

Bachelor's degree in a scientific or technical field

Tools

Veeva Vault Quality applications

Job description

Role:

Senior Manager, Quality Management Systems, overseeing the company's QRM program and supporting GxP compliance.

Responsibilities:

• lead development and continuous improvement of QRM procedures, facilitate cross-functional risk assessments using methodologies like FMEA, and ensure risk mitigation actions are tracked and addressed;
• serve as backup for Document Control and GxP Training;
• maintain inspection-ready documentation, support audit preparations, and collaborate across GMP, Clinical, CMC, and Regulatory functions. Support digital quality systems and risk-based validation of GxP computerized systems.

Requirements:

• Bachelor's degree in a scientific or technical field;
• 7+ years’ experience in Quality Assurance within biotech/pharma;
• proven expertise in building and deploying QRM programs in GxP environments;
• working knowledge of GxP regulations and global expectations;
• hands‑on experience with Veeva Vault Quality applications;
• familiarity with computer system validation and risk-based lifecycle approaches.

Preferred:

experience with APQR/PQR activities, QRM metrics, and management review reporting.

High Value:

focus on GxP compliance, risk management, inspection readiness, and digital quality systems in a biotech setting.

Work setup:

remote US-based role with periodic travel to San Francisco.