Specialist, GxP Compliance & Data Integrity Job at Beam Therapeutics (RTP, North Carolina)

Specialist Software Engineer – Industrial IoT

We are seeking a Software Engineer to join our Industrial IoT team, collaboratin...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, Computer Science, Information Systems, or related field
Master’s degree and 6 to 10 years of hands-on software development experience, OR Bachelor’s degree and 8 to 13 years of hands-on experience in industrial or manufacturing environments, using Java, Python, or other technologies
Practical exposure to IoT platforms, industrial automation systems, automation protocols such as Ethernet IP/OPC UA/MQTT and integration with SCADA/data historians
Hand on experience with Java, Python, Kubernetes or Docker, CI/CD, and hybrid (edge/cloud) IoT architectures
Ability to analyze operational data, troubleshoot system issues, and support process optimization
Experience with AWS IoT core /Greengrass or similar technology
Experience with timeseries databases such as InfluxDB, TimescaleDB

Job Responsibility

Contribute to the design, software development, deployment and maintenance of the industrial IoT platform
Develop new features for IoT platform, supporting business use cases/goals and integrating the platform with new data sources
Follow best practices for system integration, data integrity, cybersecurity, and regulatory compliance (e.g., GxP) to develop scalable and modular software solutions, adhering to SDLC requirements
Support modernization and digital transformation by developing and maintaining IoT applications and interfaces
Assist in requirements gathering, solution development, design, software development and system qualification under the guidance of a lead engineer
Collaborate with Operations, Quality, Automation, IT, and business stakeholders to ensure IoT solutions meet user needs and strategic goals
Participate in cross-functional project teams through all phases—design, build, test, deployment, and support
Help develop and maintain technical documentation, including specifications, validation protocols, and training materials
Engage in continuous learning and contribute to a culture of innovation and improvement
Support change management and system adoption across global industrial sites

New

Specialist, QC Systems

As the Specialist, QC Systems, you will support the design, implementation, and ...

Location

Canada , Vancouver

Salary:

76000.00 - 95000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Supporting the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Strong sense of community and connections through work, clubs, and socials

Fulltime

Specialist Software Development

As a Specialist at Amgen, you will be responsible for developing and maintaining...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master's degree
OR Bachelor's degree and 8 - 12 years of Information Science experience
7+ years of direct experience with Biovia OneLab ELN, Thermo Fisher Sample Manager LIMS or comparable ELN solutions
Strong understanding of system ownership responsibilities including: GxP compliance, 21 CFR Part 11 requirements, and validation
System lifecycle management, change control, and audit readiness
Ensuring data integrity and security of scientific records
Proven experience integrating and validating systems within a regulated environment (GxP, FDA, EMA)
Experience with integrating OneLab ELN, LIMS into broader Operations, R&D and IT ecosystems
Familiarity with scientific workflows (biologics, chemistry, lab processes) and ability to translate them into digital solutions
Hands-on technical skills with SQL, Python, AWS, and APIs for data workflows, automation, and system integration

Job Responsibility

Design, develop, and maintain secure, scalable applications and integrations across QC and commercial platforms (AWS, Databricks, Salesforce Marketing Cloud, Mulesoft, LIMS, ELN, and CDS)
Serve as a system owner by managing lifecycle activities (configuration, validation, upgrades, change control, documentation, and audit readiness) in compliance with GxP and 21 CFR Part 11 requirements
Collaborate with business analysts, developers, and stakeholders to gather requirements, deliver validated solutions, and support Agile/DevOps practices
Champion continuous improvement by troubleshooting issues, optimizing workflows, and evaluating new platform capabilities to enhance business value and user experience
Serve as the System Owner for Quality Control Laboratory Platforms (Sample Manager LIMS, Biovia OneLab ELN) ensuring the platform is compliant, validated, secure, and aligned with regulatory requirements
Own the system lifecycle — oversee implementation, upgrades, validation, and retirement activities, following Amgen’s system development life cycle (SDLC) and change management processes
Act as the primary liaison between product team, support team and client facing technology leads
Collaborate closely with developers and technical teams to design, configure, integrate, and validate enhancements, extensions, and interfaces
Lead and coordinate validation activities, including authoring/reviewing test scripts, managing traceability matrices, and supporting audit readiness
Manage integrations and data workflows between OneLab ELN and supporting systems, ensuring seamless interoperability and secure data exchange

What we offer

Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

IT Quality-Specialist

Join Amgen’s Mission of Serving Patients. In this vital role you will lead the e...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance
Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience
Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards
Proven experience in the validation of computerized systems (GxP)
Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP)
Experience managing quality assurance processes, including Major and Minor Deviations
Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills
Strong decision-making abilities with the capacity to drive tasks to completion
Ability to work independently with minimal supervision
Leadership skills with experience leading projects, teams, or tasks

Job Responsibility

Lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures
Supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation
Actively participate during all phases of qualification/validation of computerized systems: evaluate projects
provide guidance and technical information to others (lead qualification/validation activities)
determine and establish requirements for qualification/validation of each individual system/equipment
formulate independent decisions related to qualification/verification activities
Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis
Serve as Owner or QA Contact for Minor and Major Deviations
Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations
Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes

What we offer

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

Solutions Architect

We are seeking an experienced SAP Solution Architect to spearhead the Plan to De...

Location

United States

Salary:

152000.00 - 209000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Business, Information Technology, Engineering, or a related field
advanced degree preferred
7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes
Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management)
experience with SAP S/4HANA is a plus
Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment
Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes
Experience with in-house and contract manufacturing workflows, including batch management and material traceability
Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar
Strong analytical, problem-solving, and communication skills to bridge business and technical teams

Job Responsibility

Solution Design, Implementation & Integration: Responsible for designing, describing, and managing SAP solution design of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Deliver processes, including production planning, shop floor execution, quality management, and material management
Facilitate integration between SAP and boundary applications (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing, quality operations, and warehouse processes
Collaborate with cross-functional teams and business stakeholders to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA) and upholding “fit to standard” design principles in alignment with organizational goals
Develop and maintain functional specifications, process flows, integration plans and system configurations to ensure PTD processes scalability, reliability, and performance
Review configurations and deployments to maintain quality standards
Create clear, concise decision rationale documents balancing innovation with practicality, considering factors like cost, support, and compatibility with global end to end designs
Effectively communicate complex technical concepts to non-technical stakeholders and multifaceted business processes to technical stakeholders
Manufacturing Support: Support both in-house and contract manufacturing operations by configuring SAP solutions to manage production schedules, capacity planning, and material traceability
Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes
Quality Control & Assurance: Oversee the implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment

What we offer

company-sponsored medical, dental, vision, and life insurance plans
paid time off
discretionary annual bonus
discretionary stock-based long-term incentives

Fulltime

New

Software Development Senior Specialist

We are currently seeking a Software Development Senior Specialist to join our te...

Location

India , Noida

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Strong hands-on experience with LabVantage LIMS (v7.x / v8.x preferred)
In-depth knowledge of laboratory operations (QC, stability, sample management, batch release)
Experience with LIMS integrations (ERP, instruments, CDS, MES)
Fluent or professional-level German (spoken and written) – mandatory
Excellent English and German communication and documentation skills
Strong presentation skills with the ability to confidently interact with senior client stakeholders
Proven experience in client-facing roles or consulting engagements
Ability to manage multiple stakeholders and align business and technical teams
Strong analytical, problem-solving, and decision-making skills

Job Responsibility

Act as the primary client-facing Business Analyst for LabVantage LIMS engagements
Lead and facilitate requirements workshops, solution discussions, and stakeholder meetings in German and English
Build strong relationships with customer stakeholders across QC, QA, IT, and business teams
Clearly articulate solution designs, impacts, and benefits to non-technical audiences
Gather, analyze, and document business and functional requirements (URS, FRS, user stories)
Translate laboratory processes into LabVantage LIMS functional designs and workflows
Perform gap analysis and recommend best-practice solutions aligned with LabVantage capabilities
Support LIMS configuration including workflows, master data, and role-based access
Ensure all solutions comply with GMP, GxP, and data integrity principles
Support Computer System Validation (CSV) activities including URS, FS, IQ/OQ/PQ, and traceability matrices

Fulltime

Vice President, AI Enablement

The Vice President, AI Enablement leads Parexel’s enterprise‑wide Artificial Int...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

15+ years in data science, AI/ML, or technology leadership roles
at least 7 years in executive or senior leadership
Deep knowledge of clinical research processes, clinical data lifecycle, and pharmaceutical/life sciences regulatory expectations
Experience implementing enterprise AI platforms (GenAI, MLOps, data pipelines, automation)
Proven success operationalizing large-scale AI programs in GxP or other highly regulated industries
Familiarity with emerging AI regulations (EU AI Act, FDA, EMA expectations)
Experience with cloud-based AI ecosystems (Azure preferred)
Master’s degree or PhD in Computer Science, Data Science, Engineering, Bioinformatics, or related field preferred
Advanced business qualifications (MBA or equivalent) desirable
Excellent written and verbal communication skills

Job Responsibility

Define and evolve Parexel’s enterprise AI strategy, roadmap, and investment portfolio
Identify priority use cases aligned to business value, feasibility, and regulatory constraints
Conduct AI maturity assessments and establish long‑term capability-building plans
Co-chair AI governance
Define standards for model lifecycle management, validation, auditability, and transparency
Ensure compliance with GxP, global regulatory guidance, and responsible AI principles
Partner with Quality, Legal, and Compliance to operationalize risk management for AI systems
Oversee enterprise AI platforms, tooling, and data pipelines
Drive scalable architecture for GenAI, ML operations, retrieval‑augmented generation, and secure model hosting
Evaluate and integrate vendor platforms while ensuring data privacy and clinical-grade security

What we offer

Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities

Fulltime

Specialist, Quality Control, Chemistry

As a QC Specialist – Chemistry, you will play a key role in ensuring the quality...

Location

Spain , Madrid

Salary:

Not provided

Moderna

Expiration Date

Until further notice

Requirements

BA/BS in Chemistry (preferred) or other relevant scientific discipline with 2-5 years' experience. A student in an undergraduate program (BA/BS) is acceptable.
2-5 years of experience in quality control laboratory of a pharmaceutical company
Hands on experience with analytical chemistry testing including chromatographic techniques- HPLC, UPLC, Spectroscopic and Spectrometric techniques
Physical properties techniques such as Particle Analysis by Dynamic Light Scattering and others.
Working experience in a GMP environment.
Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
This position is site-based, requiring you to be at Moderna's site full-time.
Proficiency in English (verbal and/or written) required due to global collaboration needs.

Job Responsibility

Performing routine analytical chemistry testing such as HPLC, UPLC, UV, particle analysis, and dynamic light scattering.
Executing and supporting stability studies and GMP release testing.
Managing LIMS (LabVantage) sample result entries and executing electronic assay forms.
Assisting with method transfers and development activities across the QC Chemistry function.
Supporting special projects and ongoing initiatives in QC laboratory optimization and compliance.
Performing general laboratory operations including sample management, reagent preparation, equipment maintenance, and lab housekeeping.
Completing and maintaining cGMP documentation and ensuring full data integrity compliance.
Writing and revising SOPs, protocols, and reports in accordance with internal and external requirements.
Contributing to the training and troubleshooting activities for more junior staff.
Participating in investigations, deviations, change controls, and CAPAs within quality systems.

What we offer

Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras

Fulltime

Specialist, GxP Compliance & Data Integrity

Beam Therapeutics

Location:
United States , RTP, North Carolina

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 21, 2026

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