11h ago
Implementation Manager GxP
Boston, MA
$118k-$183k / year
full-timemid Hybridbiotech
๐ผ About This Role
You'll lead GxP implementations of the Benchling platform for biotech and pharma customers, guiding them through computer systems validation and regulatory compliance. Your core impact will be ensuring successful rollouts from kickoff to go-live while serving as a trusted advisor on validation strategy.
๐ฏ What You'll Do
- Manage GxP and non-GxP implementations of the Benchling platform from kickoff to go-live.
- Advise customers on validation strategy, risk-based approaches, and regulatory best practices.
- Guide customers through CSV activities including creating validation deliverables.
- Lead requirements workshops, data modeling, configuration, testing, and user training.
๐ Requirements
- 3-5 years of hands-on CSV experience in pharma or biotech.
- 2+ years working at a pharmaceutical or biotech company.
- Strong understanding of 21 CFR Part 11, Annex 11, and GAMP 5.
- Experience creating validation deliverables like Validation Plans, IQ/OQ/PQ protocols.
โจ Nice to Have
- Hands-on bench science or lab research experience.
- Experience using Benchling or other R&D SaaS platforms.
- Knowledge of Agile development methodologies.
๐ Benefits & Perks
- ๐ต Equity offered
- ๐๏ธ Flexible hybrid work
- โ๏ธ Travel up to 25%
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter Screenยท 30 min
- 2Hiring Manager Interviewยท 60 min
- 3Technical/Case Interviewยท 60 min
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