Implementation Manager GxP

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-s

Additional Information

We are rebuilding biotech for the AI era. When a breakthrough is delayed, the world waits. Getting a molecule from discovery to patients, or a crop from lab to field, involves thousands of slow, manual, disconnected steps. AI has the potential to change this, compressing decades of R&D work into years. But that only happens when clean, structured scientific data and AI are built into how science gets done. Benchling is the AI platform for biotech R&D. Scientists use Benchling to design experiments, capture structured data, and run AI agents and models directly in their workflows. Over 200,000 scientists around the world trust Benchling to power their most important work, from academic labs to Sanofi, Moderna, and more than half of the world's top 50 biopharma. ROLE OVERVIEW Benchling is building a world-class Professional Services team to drive implementations for our rapidly expanding customer base. We're seeking an Implementation Manager with a unique blend of systems validation expertise and customer-facing implementation skills to support our growing portfolio of GxP customers in the pharmaceutical and biotech industries. In this role, you'll leverage your project management, communication, and validation expertise to guide customers through both GxP and non-GxP implementations of the Benchling platform. You'll work hand-in-hand with research scientists, quality professionals, and IT teams at our customers, from small biotech startups to the largest biopharmas in the world, to develop a deep understanding of their R&D processes and roll out solutions that transform how their teams work together, while ensuring compliance with regulatory requirements. Implementation Managers lead all aspects of customer rollouts from requirements analysis and solution design, to configuration, testing, training, and onboarding users onto the system. Your validation expertise will be critical in helping customers understand how to validate Benchling within their quality systems and regulatory frameworks.

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