5h ago
Manager II, Enterprise Applications
Irvine, California
$134.2k-$188k / year
full-timesenior Hybridbiotech
๐ Tech Stack
๐ผ About This Role
You'll act as GxP IT system owner for Veeva Vault platforms and other validated systems. You'll ensure compliant operations through configuration, validation, and process improvements. This role offers the chance to drive system implementations in a hybrid work environment with great benefits.
๐ฏ What You'll Do
- Act as SME and IT system owner for assigned GxP applications
- Support IT roadmap and system implementations for Clinical, Regulatory, Quality
- Perform requirement gathering, risk assessment, and impact assessment
- Coordinate validation testing including UAT and ensure quality deployments
๐ Requirements
- Bachelor's degree with 8+ years of IT experience in life sciences or pharma
- 6+ years implementing and supporting GxP systems
- Strong knowledge of 21 CFR Part 11 and EU Annex 11
- Hands-on experience with Veeva Vault applications
โจ Nice to Have
- Veeva Vault certifications
- Experience with QMS, GxP LMS systems
- Working knowledge of statistical tools like Minitab or JMP
๐ Benefits & Perks
- ๐๏ธ Onsite gym
- ๐ Pool access
- ๐ฟ Snacks and drinks
- ๐ฝ๏ธ Occasional catered meals
- ๐ฐ Bonus and stock equity
๐จ Hiring Process
Estimated timeline: 4-6 weeks ยท AI estimate
- 1Phone Screenยท 30 min
- 2Technical Interviewยท 60 min
- 3Onsite Interviewยท Full day
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