CrawlJobs Logo

Implementation Manager GxP

United States, Raleigh, NC, Princeton, NJ, Philadelphia, PA 118000.00 - 183000.00 USD / Year · Job Posted February 21, 2026
Apply Position
Job Link Share

Job Description

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.

Job Responsibility

  • 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
  • Build and execute detailed project plans, own project activities, and work with other team members to execute on project deliverables
  • Serve as the GxP subject matter expert during GxP implementations, advising customers on validation strategy, risk-based approaches, and regulatory best practices
  • Guide customers through their computer systems validation (CSV) activities
  • Understand customers' scientific workflows and determine how Benchling can best be leveraged to meet their key business needs while maintaining compliance
  • 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
  • Collaborate with internal teams to ensure customer feedback on validation processes and GxP requirements influences product development
  • 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
  • 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
  • Ability to travel up to 25% based on customer and project needs

Nice to have

  • Hands-on bench science or laboratory research experience in molecular biology, biochemistry, or related fields
  • Experience using Benchling or other R&D SaaS platforms, especially as an administrator or power user
  • Software implementation or professional services experience, preferably with a SaaS company
  • Knowledge of Agile software development methodologies and software testing practices
  • Experience with lab or manufacturing systems commonly used in life sciences (LIMS, ELN, MES, QMS)
  • Experience mentoring or training others on validation principles or implementation best practices

What we offer

  • Competitive salary and equity
  • Broad range of medical, dental, and vision plans for employees and their dependents
  • Fertility healthcare and family-forming benefits
  • Four months of fully paid parental leave
  • 401(k) + Employer Match
  • Commuter benefits for in-office employees and a generous home office set up stipend for remote employees
  • Mental health benefits, including therapy and coaching, for employees and their dependents
  • Monthly Wellness stipend
  • Learning and development stipend
  • Generous and flexible vacation
  • Company-wide Winter holiday shutdown
  • Sabbaticals for 5-year and 10-year anniversaries

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Implementation Manager GxP

8 matching positions

Implementation Manager GxP

Benchling is building a world-class Professional Services team to drive implemen...
Location
Location
United States , Boston
Salary
Salary:
118000.00 - 183000.00 USD / Year
benchling.com Logo
Benchling
Expiration Date
Until further notice
Flip Icon
Requirements
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
  • 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
Job Responsibility
Job Responsibility
  • 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
  • Build and execute detailed project plans, own project activities, and work with other team members to execute on project deliverables
  • Serve as the GxP subject matter expert during GxP implementations, advising customers on validation strategy, risk-based approaches, and regulatory best practices
  • Guide customers through their computer systems validation (CSV) activities
  • Understand customers' scientific workflows and determine how Benchling can best be leveraged to meet their key business needs while maintaining compliance
  • 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
  • Collaborate with internal teams to ensure customer feedback on validation processes and GxP requirements influences product development
  • Identify and work with sales on opportunities for account expansion post go-live
What we offer
What we offer
  • Competitive salary and equity
  • Broad range of medical, dental, and vision plans for employees and their dependents
  • Fertility healthcare and family-forming benefits
  • Four months of fully paid parental leave
  • 401(k) + Employer Match
  • Commuter benefits for in-office employees and a generous home office set up stipend for remote employees
  • Mental health benefits, including therapy and coaching, for employees and their dependents
  • Monthly Wellness stipend
  • Learning and development stipend
  • Generous and flexible vacation
  • Fulltime
Read More
Arrow Right

Data Program Manager - GxP Experience

The Data Program Manager will lead the development of a GxP-validated data platf...
Location
Location
Canada , Toronto
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 10–15+ years of overall experience
  • At least 7–10 years in program/project management
  • Minimum 5+ years leading enterprise data or analytics platform programs
  • 5+ years of proven experience delivering large-scale data transformation initiatives
  • 5+ years of strong experience working in regulated environments (GxP experience highly preferred)
  • Strategic thinking with strong execution focus
  • Executive-level stakeholder management and communication
  • Strong leadership and team facilitation capabilities
  • Risk and dependency management expertise
  • Financial planning and budget oversight
Job Responsibility
Job Responsibility
  • Lead end-to-end delivery of enterprise data platform programs from strategy through execution and operationalization
  • Define program vision, roadmap, milestones, KPIs, and success metrics aligned to business objectives
  • Drive alignment between business priorities and technical execution
  • Partner with Data Engineering, Architecture, Analytics, IT, Security, Compliance, and Business stakeholders
  • Manage interdependencies across multiple projects, workstreams, and teams
  • Coordinate and oversee multiple project managers supporting various program tracks
  • Develop and maintain comprehensive program plans including scope, timelines, budgets, and resource allocation
  • Implement risk mitigation and dependency management strategies
  • Track KPIs and performance metrics to ensure value realization
  • Ensure adherence to data governance, security, compliance, and regulatory standards, especially within biosciences / GxP environments
Read More
Arrow Right

QA Associate

Proclinical is recruiting a driven QA Associate to contribute to a highly regula...
Location
Location
United States , Angleton
Salary
Salary:
Not provided
proclinical.com Logo
Proclinical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Life Sciences, Quality Management, or a related field
  • Experience in quality assurance, particularly in GxP sterile manufacturing operations
  • Strong technical understanding of manufacturing quality and regulatory requirements
  • Ability to work collaboratively in a team environment and communicate effectively with diverse groups
  • Willingness to work with radioactive materials while adhering to strict safety protocols
  • Proficiency in writing and reviewing SOPs and specifications
  • Inclusive mindset with a commitment to fostering a diverse and respectful workplace
  • Strong problem-solving skills, adaptability, and a results-oriented approach
  • Commitment to ethical behavior, continuous learning, and professional development
Job Responsibility
Job Responsibility
  • Adhere to GMP policies and ensure compliance with quality standards
  • Prepare, review, and maintain quality documents within the QMS (MasterControl), including document control and lifecycle management
  • Support training management by maintaining accurate training matrices and records
  • Assist with internal and external audits, supplier quality activities, and CMO oversight, including document reviews, audits, and quality agreements
  • Facilitate timely and compliant final product dispositions for manufactured products
  • Write, implement, and approve deviations, investigations, CAPAs, change controls, and complaint reports, ensuring timely closure
  • Ensure compliance with aseptic techniques and sterile manufacturing regulations
  • Manage supplier/vendor assurance activities and quality agreements
  • Lead FDA-regulatory interactions for site activities and products, supporting successful submissions and inspections
  • Collaborate with manufacturing, supply chain, and cross-functional teams to support batch review, release activities, and continuous QMS improvement
Read More
Arrow Right

System Engineer / System Owner for Data Historian & Rotronic Monitoring System

We are seeking a motivated, technically skilled, and communicative System Engine...
Location
Location
Switzerland , Kaiseraugst
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
August 31, 2026
Flip Icon
Requirements
Requirements
  • Degree, Technician Certification, or completed vocational training in Computer Science / Information Technology, Automation Engineering, Electrical Engineering or a comparable technical discipline
  • Strong hands-on experience with the AVEVA PI Platform
  • Advanced knowledge of PI System configuration and interface implementation
  • Experience with PLC and Process Control Systems, preferably Siemens S7
  • Experience with Computerized System Validation (CSV) and IT Qualification
  • Good understanding of Active Directory environments
  • Experience working in regulated pharmaceutical manufacturing environments
  • Proven experience within Pharmaceutical Production and GxP-regulated environments
  • Experience in Project Management
  • Strong understanding of system lifecycle management and compliance requirements
Job Responsibility
Job Responsibility
  • Serve as the System Owner for AVEVA PI and Rotronic Monitoring Systems (RMS)
  • Ensure reliable operation and lifecycle management of both systems across the Basel and Kaiseraugst sites
  • Manage system performance, availability, maintenance, and continuous improvement activities
  • Create, review, and maintain validation and qualification documentation
  • Ensure compliance with GMP, GxP, CSV, and internal quality standards
  • Support audits and inspections and coordinate remediation activities where required
  • Lead Incident, Problem, Change, and Deviation Management processes
  • Coordinate service providers and internal stakeholders to ensure timely issue resolution
  • Drive continuous service improvements and operational excellence
  • Lead and contribute to system-related projects and upgrades
  • Fulltime
Read More
Arrow Right

Senior Specialist, Quality Risk & Governance

At Amgen, we are relentless in applying the highest ethical standards to our pro...
Location
Location
United States , Thousand Oaks
Salary
Salary:
132037.30 - 178638.70 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree and 2 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • Master's degree and 4 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • Bachelor's degree and 6 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • Associate's degree and 10 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
  • High school diploma / GED and 12 years of Quality, Operations, Manufacturing, Regulatory, Clinical, or related GxP experience in biotechnology, pharmaceutical, or regulated industry experience
Job Responsibility
Job Responsibility
  • Support implementation and continuous improvement of enterprise Quality Risk Management (QRM) frameworks aligned with global regulatory expectations
  • Facilitate risk identification, assessment, mitigation, escalation, and monitoring activities across GxP functions and sites
  • Partner with cross-functional stakeholders to identify emerging compliance and operational risks across the product lifecycle
  • Support development and monitoring of Key Risk Indicators (KRIs), quality metrics, and risk dashboards to enable proactive decision-making
  • Conduct risk trending, signal analysis, and data evaluation to identify systemic issues and opportunities for mitigation
  • Assist with governance and oversight of enterprise risk registers, risk review forums, and escalation pathways
  • Collaborate with Digital and Quality Systems teams to support risk management process integration within Veeva or other quality technology platforms
  • Support inspection readiness activities and provide SME support during internal audits and regulatory inspections related to risk management processes
  • Contribute to development of training materials and risk management capability-building initiatives across the organization
  • Monitor industry trends, regulatory updates, and emerging technologies related to Quality Risk Management and digital quality transformation
What we offer
What we offer
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right

Cloud and Infrastructure Junior Engineer

We are seeking a Cloud and Infrastructure Junior Engineer with 2–4 years of rele...
Location
Location
United States , Princeton
Salary
Salary:
Not provided
rennerbrown.com Logo
Renner Brown
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2–4 years of professional experience in infrastructure engineering, cloud operations, systems administration, or a related technical discipline
  • Hands-on experience supporting at least one major cloud platform, such as Microsoft Azure, AWS, or Google Cloud Platform
  • Working knowledge of Windows Server and/or Linux administration, including user access, configuration management, and basic performance troubleshooting
  • Familiarity with virtualization and compute platforms such as VMware, Hyper-V, or cloud-native virtual machine services
  • Foundational understanding of networking concepts, including DNS, DHCP, TCP/IP, VPN connectivity, firewalls, and load balancing
  • Experience using monitoring, service management, ticketing, and documentation platforms to support operational processes and issue resolution
  • Strong analytical, troubleshooting, written communication, and cross-functional collaboration skills
Job Responsibility
Job Responsibility
  • Support the implementation, administration, monitoring, and troubleshooting of enterprise infrastructure services, including cloud platforms, servers, storage, network-connected systems, and identity services
  • Assist in incident investigation, root-cause analysis, remediation planning, and execution of corrective actions to improve platform stability, resiliency, and service performance
  • Perform routine operational activities such as patch validation, system health checks, access administration, configuration updates, and preventive maintenance in alignment with established standards
  • Identify opportunities to automate repeatable operational tasks using scripting and platform-native tooling to improve efficiency and reduce manual effort
  • Create and maintain technical documentation, including system configurations, operational procedures, architecture support materials, support runbooks, and recovery instructions
  • Contribute to test planning, validation activities, and documentation required for infrastructure changes, deployments, and controlled technology updates
  • Prepare status updates, technical summaries, and project communications for IT leadership, project teams, and business stakeholders as appropriate
  • Develop end-user and administrator guidance materials to support technology adoption, self-service enablement, and operational consistency
  • Collaborate with infrastructure, security, application, and service management teams to support project delivery across multiple business functions, locations, and time zones
  • Support technical initiatives involving Microsoft 365, Entra ID, Intune, endpoint management, cloud administration, server lifecycle activities, and network-related improvements
  • Fulltime
Read More
Arrow Right

Trial Vendor Startup Manager

Parexel is in the business of improving the world’s health. We do this by provid...
Location
Location
United Kingdom
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Advanced degree in life sciences or business with equivalent direct clinical trial project management experience
  • Fluent English communication skills, oral and written
  • Strong clinical project management experience including advanced level study start up work exposure with excellent knowledge of clinical operation processes and vendor management
  • Specific vendor category expertise – specifically such as Central Labs, eCOA/ePRO, IRT, Cardiac and Respiratory diagnostics, PR&R, Imaging reading
  • Hands on experience in User Acceptance testing (eCOA & IRT) specifically
  • Excellent knowledge of GxP and ICH regulations
  • Expert knowledge of clinical trial design and mapping to supplier requirements
  • Thorough and technical understanding of client specifications for supplier provided services
  • Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas
  • Demonstrated partnering across divisions with internal and external stakeholders
Job Responsibility
Job Responsibility
  • Interacts closely with the Vendor Program Manager to achieve study objectives specifically for its assigned categories: Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol
  • Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors
  • Quote/Proposal review in collaboration with procurement (and vendor)
  • If required, support contract negotiations
  • Vendor budget review of final quotes
  • Co-ordinates vendor kick-off meeting and other vendor specific meetings
  • Collects submission documents from vendor, as requested by countries participating in a study
  • Performs robust User Acceptance Testing (UAT) for eCOA and IRT
  • Ensures changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications
  • Supports amendment of vendor contracts with Procurement team
What we offer
What we offer
  • holiday
  • pension
  • other leading-edge benefits
  • Fulltime
Read More
Arrow Right
New

Senior Infrastructure Engineer

The Senior Infrastructure Engineer is responsible for the administration, mainte...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field, or equivalent experience.
  • 5+ years of progressive infrastructure administration experience.
  • Experience supporting biotechnology, pharmaceutical, or life sciences organizations, including work within GxP-regulated environments and experience with computer system validation (CSV), change control processes, and compliance-driven operations.
  • Experience administering AWS cloud environments.
  • Strong experience administering Linux and Windows Server environments.
  • Experience supporting network infrastructure, firewalls, VPNs, DNS, and related technologies.
  • Foundational cybersecurity experience, including vulnerability remediation, system hardening, access management, and security best practices.
  • Experience supporting backup, recovery, and disaster recovery processes.
  • Strong troubleshooting, root cause analysis, and problem-solving skills.
  • Strong written and verbal communication skills with the ability to work effectively with both technical and non-technical stakeholders.
Job Responsibility
Job Responsibility
  • Administer and support AWS cloud infrastructure, including EC2, VPCs, security groups, storage services, monitoring, and related cloud resources.
  • Administer, maintain, and troubleshoot Windows Server and Linux server environments.
  • Monitor infrastructure performance, availability, capacity, and reliability, and participate in planning, upgrades, patching, lifecycle management, and continuous improvement initiatives.
  • Maintain infrastructure documentation, architecture diagrams, technical standards, and operating procedures, and assist with development and implementation of operational processes and technical best practices.
  • Support, maintain, and troubleshoot network infrastructure, including firewalls, VPN connectivity, routing, DNS, DHCP, and wireless networking services, across cloud, server, and application environments.
  • Assist with network design reviews and infrastructure improvements, and collaborate with managed service providers and infrastructure vendors to resolve complex technical issues.
  • Design and support cloud-native and containerized workloads utilizing technologies such as Docker, ECS, EKS, and related platforms.
  • Assist with application hosting, platform administration, and infrastructure services supporting internal business systems and scientific computing workloads, and participate in cloud modernization, infrastructure automation, and platform engineering initiatives.
  • Support infrastructure requirements for data platforms, internal applications, and future AI-enabled solutions.
  • Implement and maintain infrastructure security controls and cybersecurity best practices.
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
Read More
Arrow Right