Senior GxP Systems Lead – Clinical Tech & Compliance

Structure Therapeutics; South San Francisco (CA); Hybrid; USD 166,000 - 209,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k match

Unlimited PTO

Winter shutdown

Job summary

Structure Therapeutics has an opportunity for a Senior Manager, Clinical Business Systems to oversee GxP-regulated platforms such as Veeva Vault QMS, LMS, CTMS, and eTMF, ensuring inspection readiness and scalable operations. This role partners with Quality, Regulatory, Clinical Ops, and IT to implement changes and drive process improvements.

The ideal candidate brings 8+ years in regulated pharma IT, strong vendor management, and a track record of cross-functional leadership in a fast-paced

Qualifications

• 8+ years of experience supporting GxP-regulated systems (pharma/biotech).
• Hands-on administration of GxP platforms (Veeva Vault QMS, Box, DocuSign).
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH, data integrity (ALCOA+).
• Experience with CSV/CSA activities and regulatory inspections.
• Excellent documentation, organizational, and stakeholder management skills.
• Ability to lead cross-functional technology initiatives in a fast-paced environment.

Responsibilities

• Serve as hands-on administrator for GxP apps including Veeva Vault QMS, RIM, LMS, CTMS, eTMF; Box.
• Manage day-to-day system administration, user provisioning, roles, configs.
• Coordinate releases and changes with vendors; ensure change control and validation.
• Maintain validation artifacts and system documentation; support training and adoption.
• Lead governance for inspection readiness and regulatory compliance.

Skills

Communication

Autonomy

Cross-functional leadership

Documentation

Problem solving

Agile/ITIL

Education

Bachelor's degree in Computer Science/IT/Life Sciences

Tools

Veeva Vault QMS

Box for Life Sciences

DocuSign

CTMS/eTMF/Veeva RIM

Job description

Structure Therapeutics has an opportunity for a Senior Manager, Clinical Business Systems to oversee GxP-regulated platforms such as Veeva Vault QMS, LMS, CTMS, and eTMF, ensuring inspection readiness and scalable operations. This role partners with Quality, Regulatory, Clinical Ops, and IT to implement changes and drive process improvements.

The ideal candidate brings 8+ years in regulated pharma IT, strong vendor management, and a track record of cross-functional leadership in a fast-paced