GxP Clinical Systems Lead & Compliance

Structure Therapeutics, Inc.

South San Francisco (CA)

Hybrid

USD 166,000 - 209,000

Full time

14 days+

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Benefits offered by this job

Annual performance incentive bonus
New hire equity
Ongoing performance‑based equity
Medical insurance
Dental insurance
Vision insurance
401k match
Unlimited PTO
Paid holidays including wintershutdown

Job summary

Structure Therapeutics, Inc. is recruiting a Senior Manager, Clinical Business Systems to own and govern GxP‑regulated applications. You will administer Veeva Vault QMS, RIM, LMS, CTMS, eTMF, Box and DocuSign, while coordinating with vendors and internal teams to maintain a validated, inspection‑ready environment.

You’ll drive continuous improvement, manage tickets and changes, and partner with Clinical, Quality, Regulatory and IT to align technology with business priorities.

Qualifications

  • Bachelor’s degree in a related field recommended.
  • 8+ years’ experience with GxP‑regulated systems in pharma/biotech/medical devices.
  • Hands-on admin for Veeva Vault, Box for Life Sciences, DocuSign and other regulated SaaS.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH, data integrity (ALCOA+).
  • Experience with CSV/CSA activities and validated systems.

Responsibilities

  • Serve as hands-on administrator for GxP applications (QMS, RIM, LMS, CTMS, eTMF).
  • Act as product owner, manage lifecycle, upgrades, and adoption.
  • Coordinate releases, changes, and vendor coordination with change control.
  • Support validation and maintain required documentation for a validated state.
  • Partner with stakeholders to roadmap enhancements and ensure inspection readiness.
  • Develop system documentation and user training materials.

Skills

GxP applications administration
Vendor management
Documentation & QA
Stakeholder management

Education

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

Tools

Veeva Vault QMS
Veeva Vault RIM
eTMF
CTMS
Box for Life Sciences
DocuSign Part 11

Job description

Structure Therapeutics, Inc. is recruiting a Senior Manager, Clinical Business Systems to own and govern GxP‑regulated applications. You will administer Veeva Vault QMS, RIM, LMS, CTMS, eTMF, Box and DocuSign, while coordinating with vendors and internal teams to maintain a validated, inspection‑ready environment.

You’ll drive continuous improvement, manage tickets and changes, and partner with Clinical, Quality, Regulatory and IT to align technology with business priorities.

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