Sr Principal Global Quality Systems Lead

Scorpion Therapeutics; Concord (NC); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Sr Principal (R4+) Global Quality Systems Lead to oversee and optimize Quality Management System processes that touch non-Quality areas. You will partner with manufacturing, research, clinical supply, and suppliers to standardize processes, drive improvements, and stay ahead of regulatory developments.

The role requires strong cGMP experience, quality systems expertise, and the ability to influence policy and inspection readiness across Lilly sites and partner

Qualifications

• Bachelor’s degree in a scientific, engineering, or related field.
• 7+ years of cGMP experience with knowledge in quality systems (QC, cell/gene therapy, or parenteral manufacturing).
• Lean or continuous improvement training is a plus; experience with facility/process validation is helpful.

Responsibilities

• Provide oversight and consulting to global process teams.
• Lead governance and process monitoring.
• Drive quality system improvements across functions.

Skills

Quality systems

Governance

Regulatory knowledge

Risk management

Education

Bachelor’s degree in science/engineering

Job description

Role: The Sr Principal (R4+) – Global Quality Systems Lead oversees and supports QMS processes under Global Process Ownership, ensuring alignment with the broader Quality Management System for non-Quality processes.

Responsibilities

• Providing oversight and consulting to global process teams
• Leading governance and process monitoring
• Driving quality system improvements
• Partnering across manufacturing, research, clinical supply, and external suppliers to manage risks and standardize processes
• Monitoring industry and regulatory developments
• Supporting inspection readiness
• Influencing quality policies

Requirements

• Bachelor’s in a scientific, engineering, or related field
• Minimum 7 years of cGMP experience with knowledge in quality systems, particularly in areas like Quality Control, cell and gene therapy, or parenteral manufacturing
• Preferred skills include experience with risk management, process validation, GMP utilities, and knowledge of ICH, PIC/S, and WHO standards
• Additional qualifications may include formal training in Lean or continuous improvement, and experience supporting facility or process validation

HighValue: Focus on biopharma manufacturing, quality system governance, and compliance in cGMP environments, with some travel (~10%) and hybrid work setup based in Indianapolis, Indiana or other Lilly sites.