Implementation Manager GxP Job at Benchling (Boston)

Manufacturing Relationship Manager

The Manufacturing Relationship Manager for Round Lake Drug Delivery (RLDD) is ac...

Location

United States , Round Lake

Salary:

120000.00 - 165000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in IT, CS, Business Process Management or related discipline or equivalent number of years of work experience
Have a minimum of 7 years of technical knowledge and 5+ years of IT business engagement experience, preferably in a manufacturing environment
Experience working in a GxP environment particularly in the Cell Therapy, BioTech, or Pharma industries strongly preferred
Experience working with IT systems that integrate with industrial automation is strongly preferred
Possess good communication skills to promote cross functional discussions and be able to explain potentially complex solutions to the customer
Experience working on cross functional teams to obtain project deliverables

Job Responsibility

Partner closely with the assigned plant managers, shared service supply chain functions, and Segment business and IT management
Build, share and drive adoption of the 'art of the possible' in how technology can be applied in different ways to help the financial position and strategic objectives of manufacturing within the Segment
Develop and lead a plant manufacturing technology strategy and technology roadmap with alignment to the business plan and IT capabilities, constantly pursuing standardization and TCO reduction
Ensure the plant technology roadmap provides vulnerability management by ensuring systems are running on modern and supported infrastructure
Understand key financial drivers and strategic goals for the assigned plants in the Segment
Ensure projects are aligned to these business objectives
Collaborate with executives and other leaders to define the long-term IT and application roadmap
Partner closely with the business leaders and IT leadership in setting priorities, placing realistic expectations on scope delivery and project
Act as an SME and teacher to other members of the manufacturing teams and IT in support of continuous improvement, customer focus and innovation
Responsibility for IT budget and accuracy of the forecast

What we offer

Paid Time Off
Employee Health & Well-Being Benefits
Continuing Education/Professional Development
Support for Parents
Employee Assistance Program
Medical and dental coverage
Basic life insurance
Accident insurance
Short-term and long-term disability insurance
Business travel accident insurance

Fulltime

Regulatory Data & Systems Manager

The Regulatory Data & Systems Manager will be responsible for facilitating syste...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies
Excellent oral and written communication skills
able to organize and present ideas in a convincing and compelling manner
Ability to operate effectively in a matrix environment
team player yet able to work independently with minimal direction
Familiarity with GxP requirements and systems validation
Life Sciences, Biotech or pharmaceutical industry experience preferred
Proven Veeva Vault knowledge
Bachelor’s degree and 2 years of directly related experience

Job Responsibility

System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements
Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices
Project Coordination: Assist in planning, tracking, and executing departmental projects and initiatives
Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Implementation Manager GxP

Benchling is building a world-class Professional Services team to drive implemen...

Location

United States , Raleigh, NC, Princeton, NJ, Philadelphia, PA

Salary:

118000.00 - 183000.00 USD / Year

Benchling

Expiration Date

Until further notice

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

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

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

Sr Associate IS Analyst - Veeva Vault Release Engineer

In this vital role in Amgen Veeva Release Management team and focuses primarily ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s or Bachelor’s degree
5 to 9 years of Computer Science, Information Systems or Related IT work experience
Experience with Veeva Vault Platform and Products, including Veeva configuration settings and custom builds
5 - 7 years of experience working in global pharmaceutical Industry
Experience in building configured and custom solutions on Veeva Vault Platform
Experience in managing systems, implementing and validating projects in GxP regulated environments
Extensive expertise in SDLC, including requirements, design, testing, data analysis, creating and managing change controls
Proficiency in programming languages such as Python, JavaScript etc.
Strong understanding of software development methodologies, including Agile and Scrum
Excellent written and verbal communication skills

Job Responsibility

Support in development and implementation of the release management process for Amgen Veeva Vault platform
Manage release plans, including timelines, resources, and risk assessments
Collaborate with IT and business teams to facilitate smooth and efficient Veeva releases
Assess and plan for the impact of Veeva changes and releases on partners
Assists to develop and managing communication plans to engage Veeva partners and provide clear messaging
Support designing and delivery of training programs, offering ongoing support and coaching
Be part of change impact evaluations
Oversee planning, scheduling, and coordination of Veeva releases, ensuring alignment with change management strategies

What we offer

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Data Program Manager - GxP Experience

The Data Program Manager will lead the development of a GxP-validated data platf...

Location

Canada , Toronto

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

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

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

Manager/Sr. Manager, Global Compliance and Training

The Manager/Sr. Manager, Compliance and Training, will provide expertise in trai...

Location

United States , Durham, NC

Salary:

125000.00 - 190000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in scientific discipline/Life Sciences or equivalent experience in the biotech or pharmaceutical industry
8+ years of relevant experience in a GMP and GXP environment with at least 3 years of demonstrated experience with the development, maintenance, and training oversight required
General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry
Skilled in determining the state and needs of the learner and defining the end goal of instruction
Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills
Ability to work independently
Excellent computer skills and advanced knowledge of Quality Systems
Direct experience with Quality Management Systems, Document Management Systems, Learning Management Systems, and Microsoft Office, including Word and Excel
Veeva experience required
Self-motivator with the ability to follow up on and complete multiple projects simultaneously

Job Responsibility

Develops, leads, and implements training initiatives that are aligned with business strategies
Design, develop and deliver instructional materials, both digital and physical, in an efficient, effective, appealing, engaging way
Manages the performance/effectiveness of quality system training programs
Work collaboratively on the GXP integrated digital landscape to support, resolve system technical issues and communicate best practices for electronic quality training systems
Assist in the refinement of system user training and support training delivery
Assist in improving and maintaining Beam’s overall Quality Management System (QMS), including policies and procedures, while keeping them current with emerging and changing regulations
Develops user requirements regarding Quality training systems and supports the generation/review/approval of computer system validation deliverables
Contributes to the generation, review, and approval of computer system test scripts
Support site and function audit preparations with respect to system functionality
Support development of harmonized/streamlined/standardized processes and supplemental documents (including Work Instruction creation or maintenance) governing management and usage of Quality Systems

Fulltime

Project Manager/Sr. Consultant

We are looking for an experienced Project Manager/Sr. Consultant to contribute t...

Location

United States , San Francisco

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience in creating and implementing Quality Management Systems for pharmaceutical or life sciences organizations
Deep understanding of GxP compliance, including 21 CFR Part 11 and EU Annex 11 regulations
Familiarity with Agile Scrum methodologies and their application in project management
PMP Certification or equivalent project management qualifications
Strong background in IT project management, with a focus on compliance-driven environments
Ability to work independently and effectively in fast-paced, engineering-focused settings
Expertise in using project management tools such as Atlassian Jira
Excellent communication skills to collaborate with engineering teams and represent the organization during audits

Job Responsibility

Lead the creation of a Quality Management System, including authoring the Quality Manual, SOPs, and validation packages
Collaborate with engineers to ensure clinical data workflows align with GxP compliance requirements
Serve as the primary quality function, managing documentation and compliance processes from the ground up
Represent the organization during audits, defending the quality systems and documentation developed
Educate engineering teams on the importance of GxP regulations and compliance standards
Make informed decisions regarding scoping and implementation based on regulatory knowledge, including 21 CFR Part 11 and EU Annex 11
Develop strategies to address vendor qualification audit findings and implement remediation plans
Utilize Agile Scrum methodologies to manage project timelines and deliverables efficiently
Oversee IT project management tasks, ensuring alignment with overall compliance objectives
Use tools such as Atlassian Jira to track project progress and maintain transparency across teams

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in company 401(k) plan

SAP Architect - QM/PP-PI

In this vital role you will be responsible for designing, configuring, and integ...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with 1 to 3 years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules
Bachelor’s degree with 3 to 5 years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules
Diploma with 7 to 9 years of IT or years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules
Strong Hands-on in end-to-end QM processes: inspection planning, notifications, batch management, and audit handling
Strong Hands-on in production & planning, master data, Material masters, BOM, Resource, Recipe, production version, Demand management, MRP, process orders etc.
Experience in regulated environments (Life Sciences, Biotech, or pharmaceutical industry)
Deep understanding of GxP, GMP, and FDA 21 CFR Part 11 requirements
Experience working in multi-site or global SAP S/4 rollouts
Ability to design and implement solutions based on business requirements, including debugging and root cause analysis
Experience in creating detailed documentation, including functional specifications, test cases, and compliance reports

Job Responsibility

Design, configuration, and implementation of SAP S/4HANA Quality Management processes
Design, configuration, and implementation of SAP S/4HANA PP-PI module aligned with life sciences manufacturing best practices
Translate business requirements into SAP QM functional specifications aligned with life sciences regulatory needs (GxP, GMP, FDA 21 CFR Part 11, ISO 9001)
Configure inspection planning, results recording, usage decisions, and quality notifications
Support integration with related modules including MM (Procurement), PP (Production), PM (Maintenance), and EWM (Warehouse Management)
Conduct architectural reviews and assessments to identify potential risks and recommend mitigation strategies
Creation and maintenance of critical documentation such as technical assessments, configuration specs, functional designs, test cases, and user manuals
Ensure compliance with pharmaceutical industry standards and regulations
Participate in sprint planning, reviews, and retrospectives to deliver and sustain Amgen's S/4HANA ecosystem utilizing the Scaled Agile Framework (SAFe)
Develop innovative solutions that drive speed to value via AI/ML and leading practices

What we offer

Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment

Fulltime

Implementation Manager GxP

Benchling

Location:
United States , Boston

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 21, 2026

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