Sr. Mgr., Quality Management Systems
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
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.
- 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.
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.
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