Hybrid Implementation Manager – GxP

at Benchling

• Job title: Implementation Manager – GxP
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: $118,000 - $183,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Boston, United States

About the role

• Implementation Manager overseeing GxP customer rollouts in biotech at Benchling. Driving implementations and ensuring compliance for a growing portfolio of clients in regulated environments.

Responsibilities

• Manage initial rollouts for new Benchling customers as well as expansion projects with new teams or for new processes at existing customers, with particular focus on GxP and regulated environments.
• Own implementation success from project kickoff to go-live, leveraging strong project management skills, validation expertise, and deep product knowledge.
• Build and execute detailed project plans, own project activities, and work with other team members to execute on project deliverables to ensure on-time, on-budget, high-quality deployments.
• Serve as the GxP subject matter expert during GxP implementations, advising customers on validation strategy, risk-based approaches, and regulatory best practices for implementing Benchling within their quality systems.
• Guide customers through their computer systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports) aligned with their internal procedures and regulatory requirements.
• Understand customers' scientific workflows and determine how Benchling can best be leveraged to meet their key business needs while maintaining compliance with relevant regulations (21 CFR Part 11, Annex 11, GxP).
• Lead requirements and design workshops, perform data modeling and application configuration, develop test plans and guide UAT execution, train and onboard users.
• Act as a trusted advisor for customers, guiding them through the implementation ensuring they leverage and apply Benchling best practices for both scientific workflows and regulatory compliance.
• Collaborate with internal teams to ensure customer feedback on validation processes and GxP requirements influences product development and validation package improvements.
• Identify and work with sales on opportunities for account expansion post go-live.

Requirements

• B.S. in engineering, life sciences, biological sciences, or a related field.
• 3-5 years of hands-on experience with computer systems validation (CSV) in pharmaceutical, biotech, or other regulated life sciences environments.
• 2+ years of experience working at a pharmaceutical company, biotech, or similar regulated organization.
• Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and principles of computer systems validation in GxP environments.
• Experience creating or reviewing validation deliverables such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Demonstrated ability to apply risk-based validation approaches and advise on validation strategy.
• Strong communication skills with the ability to quickly and effectively connect with a range of stakeholders, including scientists, quality professionals, IT project leads, and executives.
• Strong project management skills with the ability to manage multiple workstreams and stakeholders simultaneously.
• Self-starter with the ability to be successful in a fast-paced environment.
• Curious, creative, and tenacious. You should be excited to collaborate with customers and other Benchling teammates as a thought partner.
• Ability to travel up to 25% based on customer and project needs.

Benefits

• Full-time U.S. employees enjoy a comprehensive benefits program including equity
• health, dental, vision
• 401(k)+ employer match
• wellness
• commuter