Implementation Manager GxP
Raleigh, NC$139k - $183kFull-timePosted 10mo ago
About the role
Managing customer implementations with expertise in GxP and validation processes to ensure compliant deployment of Benchling platform in regulated environments.
Responsibilities
- Manage initial rollouts for new Benchling customers and expansion projects in GxP and regulated environments.
- Own implementation success from project kickoff to go-live, utilizing project management, validation expertise, and product knowledge.
- Build and execute detailed project plans, coordinate team activities to ensure timely, on-budget high-quality deployments.
- Serve as GxP SME during implementations, advising on validation strategies, risk-based approaches, and regulatory compliance.
- Guide customers through computer systems validation (CSV), including creation of validation deliverables (Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports).
- Understand customer scientific workflows and align Benchling implementations to meet key business needs while maintaining compliance with regulations like 21 CFR Part 11, Annex 11.
- Lead requirements gathering, design workshops, data modeling, application configuration, test plan development, UAT, and user onboarding.
- Act as a trusted advisor on Benchling best practices for scientific workflows and regulatory compliance.
- Collaborate with internal teams to incorporate customer feedback into validation processes and product improvements.
- Identify opportunities for account expansion post go-live.
Qualifications
- B.S. in engineering, life sciences, biological sciences, or related field.
- 3-5 years of hands-on experience with computer systems validation (CSV) in pharmaceutical, biotech, or regulated 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 GxP validation principles.
- Experience creating or reviewing validation deliverables such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, Validation Summary Reports.
- Ability to apply risk-based validation approaches and advise on validation strategy.
- Strong interpersonal and communication skills for engaging with scientists, quality professionals, IT leads, and executives.
- Good project management skills with the ability to handle multiple stakeholders and workstreams.
- Self-starter mentality, success in fast-paced environments.
- Curious, creative, tenacious attitude, eager to collaborate.
Skills
Required:Project ManagementValidation ExpertiseRegulatory KnowledgeCommunication Skills
Benefits
- Competitive salary and equity.
- Broad medical, dental, and vision plans for employees and dependents.
- Fertility healthcare and family-forming benefits.
- Four months of fully paid parental leave.
- 401(k) with employer match.
- Commuter benefits and home office stipend.
- Mental health benefits, including therapy and coaching.
- Monthly Wellness stipend.
- Learning and development stipend.
- Flexible vacation policy.
- Company-wide winter shutdown.
- Milestone sabbaticals after 5 and 10 years.
Last updated Jan 16, 2026. Interested? Apply on the company site.
About Benchling
Cloud-based platform for biotech R&D | Benchling
Benchling is a cloud-based platform for biotechnology research and development and the only biology-first platform for scientific data, collaboration, and insights.
BioresearchBioprocessIn VivoConnectGene therapyCell therapyAntibodies and proteinsRNA therapeutics
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