Implementation Manager GxP
Boston, MA$125k - $183kFull-timePosted 10mo ago
About the role
Lead customer GxP and non-GxP system implementations, ensuring compliance with regulatory standards, and advising on validation strategies within the biotech and pharmaceutical industries.
Responsibilities
- Manage initial rollouts for new Benchling customers and expansion projects involving GxP environments.
- Own implementation success from project kickoff to go-live, including project planning, validation, and deployment.
- Build and execute detailed project plans ensuring on-time, on-budget delivery.
- Serve as GxP subject matter expert, advising customers on validation strategies, risk assessments, and regulatory compliance.
- Guide customers through computer systems validation activities, creating validation deliverables aligned with internal procedures and regulatory frameworks.
- Understand customer workflows to optimize Benchling's use while maintaining compliance with regulations (21 CFR Part 11, Annex 11, GxP).
- Lead requirements gathering, design workshops, data modeling, configuration, testing, training, and onboarding.
- Act as a trusted advisor to ensure customers leverage best practices for scientific workflows and compliance.
- Collaborate with internal teams to incorporate customer feedback into validation processes and product features.
- Identify opportunities for account expansion post-implementation.
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 regulated life sciences environments.
- 2+ years experience in a pharmaceutical or biotech 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, Risk Assessments, Traceability Matrices, Validation Summary Reports.
- Ability to apply risk-based validation approaches and advise on validation strategies.
- Strong communication skills for engaging stakeholders from scientists to executives.
- Excellent project management skills managing multiple workstreams.
- Self-starter capable of excelling in a fast-paced environment.
- Curious, creative, tenacious, and collaborative mindset.
- Ability to travel up to 25% as needed.
Skills
Required:Project ManagementValidation & Regulatory ComplianceCommunication Skills
Benefits
- Competitive salary and equity.
- Broad range of medical, dental, and vision plans.
- 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.
- Sabbaticals at 5 and 10-year milestones.
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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