Manager II, Enterprise Applications (R&D & GxP Systems)
Tarsus Pharmaceuticals, Inc.
12 hours ago
Remote friendly (Orange County, CA)
United States
IT
Responsibilities:
- Act as subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault and other validated systems supporting Clinical, Regulatory, Quality, and other regulated functions.
- Support execution of the IT roadmap and system implementations (requirements gathering, risk/impact assessment, solution design, configurations, testing, and validation).
- Perform requirement gathering, risk assessment, and impact assessment for new implementations and system changes.
- Collaborate with business stakeholders, IT, Quality, and external vendors to implement systems and provide day-to-day operations support.
- Partner with Quality/vendor partners on GxP operations, change management, CAPAs, periodic reviews, inspection readiness, and audit/inspection support (including presenting documentation).
- Coordinate and support validation testing, including UAT, and ensure quality production deployments.
- Own IT activities for change control requests and provide required GxP documentation.
- Assist with data management, migration, integration, and analytics across GxP systems.
- Manage periodic reviews, upgrades, and releases (including release assessments).
- Drive process improvements to enhance system efficiency and effectiveness.
- Contribute to development/review/maintenance of SOPs, work instructions, and policies for GxP systems.
- Ensure assigned systems remain inspection-ready with complete, accurate, and defensible validation/compliance documentation.
Qualifications & Skills:
- Bachelor’s degree in CS/IS/Engineering/Quality/Regulatory/Business; 8+ years relevant IT experience in life sciences/pharma.
- 6+ years implementing and supporting GxP systems (clinical, regulatory, quality, and other GxP applications).
- Strong understanding of SDLC and GxP validation; knowledge of 21 CFR Part 11, EU Annex 11, and GxP compliance (ICH GCP familiarity plus).
- Hands-on Veeva Vault experience (RIM, CTMS, eTMF) strongly preferred; Veeva certifications plus.
- Experience with QMS, GxP LMS, or other GxP systems plus.
- Statistical tools (e.g., Minitab, JMP); JReview exposure plus.
- Familiarity with waterfall and Agile.
- Strong communication/problem-solving; ability to work independently and drive accountability.
- Experience managing vendors, system integrators, and SaaS providers.
- Commitment to staying current on new technologies/industry trends.
Benefits & Logistics (if part of posting):
- Hybrid work environment; Irvine, CA (onsite). Some travel up to 10%.
Expected Pay & Benefits (as stated):
- Base pay range: $134,200–$188,000 plus bonus, stock equity, and comprehensive benefits (health, dental, vision); generous paid time off.
- Act as subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault and other validated systems supporting Clinical, Regulatory, Quality, and other regulated functions.
- Support execution of the IT roadmap and system implementations (requirements gathering, risk/impact assessment, solution design, configurations, testing, and validation).
- Perform requirement gathering, risk assessment, and impact assessment for new implementations and system changes.
- Collaborate with business stakeholders, IT, Quality, and external vendors to implement systems and provide day-to-day operations support.
- Partner with Quality/vendor partners on GxP operations, change management, CAPAs, periodic reviews, inspection readiness, and audit/inspection support (including presenting documentation).
- Coordinate and support validation testing, including UAT, and ensure quality production deployments.
- Own IT activities for change control requests and provide required GxP documentation.
- Assist with data management, migration, integration, and analytics across GxP systems.
- Manage periodic reviews, upgrades, and releases (including release assessments).
- Drive process improvements to enhance system efficiency and effectiveness.
- Contribute to development/review/maintenance of SOPs, work instructions, and policies for GxP systems.
- Ensure assigned systems remain inspection-ready with complete, accurate, and defensible validation/compliance documentation.
Qualifications & Skills:
- Bachelor’s degree in CS/IS/Engineering/Quality/Regulatory/Business; 8+ years relevant IT experience in life sciences/pharma.
- 6+ years implementing and supporting GxP systems (clinical, regulatory, quality, and other GxP applications).
- Strong understanding of SDLC and GxP validation; knowledge of 21 CFR Part 11, EU Annex 11, and GxP compliance (ICH GCP familiarity plus).
- Hands-on Veeva Vault experience (RIM, CTMS, eTMF) strongly preferred; Veeva certifications plus.
- Experience with QMS, GxP LMS, or other GxP systems plus.
- Statistical tools (e.g., Minitab, JMP); JReview exposure plus.
- Familiarity with waterfall and Agile.
- Strong communication/problem-solving; ability to work independently and drive accountability.
- Experience managing vendors, system integrators, and SaaS providers.
- Commitment to staying current on new technologies/industry trends.
Benefits & Logistics (if part of posting):
- Hybrid work environment; Irvine, CA (onsite). Some travel up to 10%.
Expected Pay & Benefits (as stated):
- Base pay range: $134,200–$188,000 plus bonus, stock equity, and comprehensive benefits (health, dental, vision); generous paid time off.