itcss
Manager II, Enterprise Applications (R&D & GxP Systems)
Irvine, California, United States · Mid
Sponsorship not specified$134k-$188kDetected 53 days ago
GCPProject ManagementAgileRecruitingHRCommunicationCollaborationProblem SolvingPublic SpeakingGxP
About the role
- Act as a subject matter expert and IT system owner for assigned GxP applications, including Veeva Vault platforms and other validated systems supporting Clinical, Regulatory, Quality and other regulated functions
- Assist with data management, migration, integration, and analytics across GxP systems, ensuring business needs are met
- Contribute to the development, review, and maintenance of SOPs, work instructions, and policies related to GxP systems
Responsibilities
- Collaboration and Team Building
- Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
- Collaborate with business stakeholders, IT, Quality and external vendors to implement new systems and provide day-to-day operations support for assigned GxP systems
- Coordinate and support validation testing including user acceptance testing (UAT) of system changes and ensure quality production deployments
- Manage periodic reviews, upgrades and releases including release assessments.
- Collaborate with cross-functional teams and support the business stakeholders to identify and implement process improvements, enhancing system efficiency and effectiveness
- Experience managing vendors, system integrators, and SaaS providers in both project and support contexts
- Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.
Requirements
- Review and own IT activities for change control requests and provide all required documentation for GxP systems
- Some travel may be required - up to 10%
Nice to have
- Bachelor's degree in Computer Science, Information Systems, Engineering, Quality, Regulatory, or Business, with 8+ years of relevant IT experience in the life sciences or pharmaceutical industry
- 6+ years of experience implementing and supporting GxP systems, including clinical, regulatory, quality and other GxP applications
- Solid understanding of business processes, System Development Lifecycle (SDLC) and validation in a GxP-regulated setting, including strong knowledge of 21 CFR Part 11, EU Annex 11, and GxP compliance practices
- familiarity with ICH GCP regulations is a strong plus
- Hands-on experience with Veeva Vault applications (e.g. RIM, CTMS, eTMF ) strongly preferred
- certifications in Veeva Vault modules are a plus
- Experience working with a QMS, GxP LMS systems or other GxP systems is a plus
- Working knowledge and familiarity with statistical tools (e.g., Minitab, JMP)
Skills
- Your Human Resources Team
Compensation
- The expected base pay range for this position is $134,200 - $188,000 plus bonus, stock equity, and comprehensive benefits.
Benefits
- Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
- The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
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