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

New

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

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

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

Senior IT Engineer – Research & Development

The Senior IT Engineer – R&D acts as the interface between the R&D business unit...

Location

Italy , Bologna; Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Bachelor's or Master’s Degree in Information Technology, Statistics, Biotechnology or other relevant field
4–6 years of experience in IT in the Life Sciences/Biotech/Pharma sector
Solid understanding of IT R&D processes and/or application management with a proven track record of delivering results across multiple project settings
Strong understanding of the R&D Pharma environment and experience in one or multiple areas such as e.g. Clinical, Pharmacovigilance, Regulatory, Medical Affairs
Knowledge of R&D software such as electronic Trial Master Files, Clinical Data Management solutions, Pharmacovigilance and Regulatory applications
Experience with GxP and GAMP5 frameworks
Proven experience in managing vendor relationships
Familiarity with Agile, Scrum, and/or Waterfall methodologies and ideally Project Management tools (e.g. SmartSheet, Microsoft Project)
Proficiency in Microsoft Office Suite
Strong communication and stakeholder management skills

Job Responsibility

Collect and analyze business requirements from R&D stakeholders
Translate business needs into functional and technical specifications
Collaborate with IT teams (architecture, development, support) to evaluate feasibility and define solution proposals for R&D use cases
Support the management of software implementations and data migration projects for the R&D solutions’ portfolio
Support the prioritization of initiatives based on business value, urgency, and alignment with strategic objectives
Contribute to the evaluation and development/implementation of AI initiatives for R&D use cases
Monitor the demand pipeline and maintain a clear overview of ongoing and planned IT R&D initiatives
Facilitate workshops and meetings between business and IT to ensure shared understanding and alignment
Contribute to building business cases for new IT R&D initiatives
Support change management activities and user adoption of delivered solutions

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

New

Senior Facilities Manager

The Senior Facilities Manager is the key strategic and operational leader respon...

Location

United States , South San Francisco

Salary:

145900.00 - 182400.00 USD / Year

JLL

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering (or equivalent technical degree) or related field recommended
10+ years in facilities management, with a minimum of 5 years in a leadership or managerial capacity overseeing multi-disciplinary teams and integrated facilities operations
Proven experience leading an integrated facilities platform in a complex, multi-stakeholder corporate or industrial environment
Proficiency with Computerized Maintenance Management Systems (SAP preferred) and demonstrable competence in managing site operating budgets within financial systems
Deep understanding of mechanical, electrical, HVAC systems and related building infrastructure assets
Proven accountability for oversight and management of GxP, OSHA, and environmental compliance (Air, Water, Waste Management) in a regulated setting
Skilled in strategic business planning, financial forecasting, and resource allocation
Ability to influence results without direct authority, superior stakeholder and vendor relationship management, and excellent verbal and written communication
Ability to work in mechanical rooms, electrical areas, and confined spaces
Must be able to climb ladders, work at heights, and occasionally lift up to 50 lbs.

Job Responsibility

Facility Operations Leadership: Provide strategic oversight and technical governance for maintenance, utilities, lab services, and all facility operations while serving as the single point of accountability for operational performance to key client stakeholders and technical escalation point for complex facility issues
Compliance & Safety Management: Ensure strict adherence to all EHS, GMP, GxP standards, and local, state, federal regulations while establishing a Safety First culture and managing compliance with portfolio-wide initiatives and regulatory requirements
Asset & Maintenance Strategy: Oversee critical equipment vendor preventive maintenance schedules, develop long-term maintenance strategies for asset renewal and replacement, and govern maintenance backlog strategy including aging, critical, and GMP overdue mitigation
Team Leadership & Development: Manage site-level organizational structure ensuring appropriate staffing levels and skill sets, establish SMART objectives, provide superior employee management, actively develop team members, and maintain effective succession planning for all positions
Financial Management: Effectively manage site operating expenses to meet/exceed glide path savings targets, own development and management of operating budgets, provide timely financial variance analysis, and update 5-year facility capital/operating improvement project plans
Vendor & Contract Management: Maintain interface with third-party vendors ensuring total contract compliance, standardize service level agreements and scopes of work, support JLL Sourcing initiatives for vendor consolidation, and manage scope transitions following established JLL processes
Client Relationship Management: Measure and manage client feedback throughout the year, conduct formal and informal relationship meetings, serve as liaison for all services including janitorial, lab services, grounds, security, and waste management
Process Improvement & Innovation: Spearhead identification, development, and implementation of innovative best practices to increase operational efficiency, maintain site risk registers, lead business continuity planning, and conduct post-incident reviews for continuous improvement
Performance Monitoring: Monitor and improve planning and scheduling effectiveness including schedule compliance and backlog health, verify contractual KPI compliance, maintain documentation supporting performance reporting, and ensure vendor partners meet client expectations and SOW requirements
Strategic Support & Growth: Support Account Team on scope change initiatives and priority projects, actively seek scope expansion opportunities, demonstrate ability to apply new technology and corporate programs, and promote customer and JLL sustainability initiatives

What we offer

401(k) plan with matching company contributions
Comprehensive Medical, Dental & Vision Care
Paid parental leave at 100% of salary
Paid Time Off and Company Holidays
Early access to earned wages through Daily Pay

Fulltime

Laboratory Manager

In this position, the successful candidate will oversee and guide the day-to-day...

Location

United Kingdom , Cambridge

Salary:

Not provided

Avantor

Expiration Date

Until further notice

Requirements

A Bachelor’s degree in a scientific discipline, preferably Biochemistry, or equivalent laboratory experience
Proven excellent customer service focus and ability to work collaboratively
Clear and concise written and spoken communication skills
Ability to influence people at all levels to deliver improvements and cost savings to the customer
Some knowledge and experience of lean sigma processes is an advantage
Able to partner with other teams and suppliers and deliver results in a matrix environment, managing multiple internal and external partners/stakeholders.
Excellent problem-solving capabilities and confidence to make clear decisions sometimes with limited information.
Exceptional planning, organisational, analytical and networking skills.
Project management skills, ability to be flexible and handle multiple responsibilities and tasks on a regular basis
Proficient in data capture, analysis and reporting utilising various IT systems particularly Microsoft Excel

Job Responsibility

Operational day to day Laboratory management providing a ‘single point of contact‘ for laboratory scientists and external visitors
Ensures the laboratory maintains its operational efficiency by liaising with all FM suppliers - planning preventative and scheduled maintenance regimes with minimal impact to daily operations, ensuring any FM helpdesk requests are completed
Assists with organised visits from internal/external partners and regulatory bodies
Maintains and organises laboratory consumable inventories and provides reports to the Dept leadership team as requested
Performs laboratory inductions for internal/external and temporary lab users working in the area to familiarise them will lab policies and procedures
Provide operational support on projects to build understanding of business needs and identify opportunities for process improvements
Co-ordinate laboratory scientists to ensure 6-monthly laboratory cleans are completed effectively
Maintain and update the orientation plan for new starters
Knowledge or experience of equipment IQ/OQ/PQ
Serves as a committee member on several cross functional teams including: SHE Safety Committee, Operations Lab Rep meetings. Ensure relevant actions are implemented with Research labs

What we offer

competitive salary and benefits package
flexible approach to work

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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