Deployed GXP Specialist Job at Helpcare AI (London)

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

IT Quality - AI Specialist

This role is accountable for the end-to-end global process that ensures AI-enabl...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree with a minimum of 10 years experience in Software and Systems Quality assurance
Bachelor’s degree with a minimum of 12 years of Software and Systems Quality assurance experience
Demonstrated experience in GxP computerized systems validation/qualification and lifecycle management
Experience developing, maintaining, and deploying controlled documents and templates within a regulated QMS environment
Familiarity with AI governance expectations in GxP contexts, including responsible-use constraints such as human oversight and independent verification
Working knowledge of AI trustworthiness/credibility assessment concepts and documentation practices used to support validation decisions
Strong process orientation and document quality discipline (controlled documentation, traceability, clarity)
Ability to influence without authority across global, cross-functional stakeholders
Risk-based thinking and ability to translate policy/standards into practical, scalable validation deliverables
Clear written and verbal communication

Job Responsibility

Maintain a compliant global quality process for AI validation/qualification and ensure alignment with QMS architecture and global documentation expectations
Define and maintain the global procedural framework for validating AI-enabled GxP systems, including integration points with system validation/SDLC expectations and responsible-use controls
Ensure the process is risk-based and scaled to AI context of use and impact, with clear decision gates and required evidence expectations
Robust understanding on the LLM and Machine development life cycle approaches
Able to support in shifts based on the project needs in EST, PST Timezone
Own/maintain the core global procedures and templates supporting AI validation/qualification, including credibility/trustworthiness assessment documentation and controlled report formats
Ensure documents are periodically reviewed and revised consistent with QMS role expectations for global process ownership
Partner with the Responsible Use BPO and governance stakeholders to ensure validation/qualification requirements align with responsible-use constraints (e.g., independent human verification and traceability expectations)
Coordinate with QA, Business Owners, System SMEs/IT Application Owners, and AI Model SMEs to ensure validation deliverables reflect business, compliance, and IS requirements and are stored in appropriate controlled repositories
Provide execution guidance, coaching, and job aids to sites/functions on implementing the global AI validation/qualification process locally while maintaining global consistency

Process and Procedural Document Specialist, Sr. Manager

Parexel FSP is hiring a Process and Procedural Document Specialist, Sr. Manager ...

Location

Argentina; Brazil; Mexico , Remote; Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

A minimum of a BA or BS is required, advanced degree in relevant field desirable. Degree or professional certification in process design or change management, or equivalent experience
A minimum 5-8 years of experience in design and documentation of pharmaceutical business processes (safety, regulatory, medical and/or clinical). Demonstrated process development expertise
Ability to manage multi-phase moderately complex projects with multiple contributors/collaborators, facilitate cross functional global or enterprise teams, optimize subject matter involvement, and interacts at all levels in a matrix environment. Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines
strong planning and multi-tasking skills
Ability to lead by example, demonstrating the sponsor’ values and effectively implement strategies through influence and persuasion
Demonstrate ability to adapt to changing situations and work well under pressure
Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project)
tools for process design and mapping
and systems for document management, publishing, communication, and learning management
Understanding of the fundamentals of electronic publishing of procedural documents

Job Responsibility

Lead a matrix team comprised of global and/or local subject matter experts, business process owners, and key stakeholders, with minimal assistance, in the development, revision, process mapping, process enhancements, implementation and maintenance of process quality standards and procedural documentation (policies, SOPs and associated documents) for approximately 10,000 colleagues across the sponsor’ clinical, medical, safety, regulatory and enterprise quality management system global processes
Function as a key subject matter expert in the document management model, quality management system, and quality standards. Providing advice and recommendations to global and local colleagues on process enhancement and continuous improvement project teams. provide strategic recommendations regarding process design, documentation development, change management and supporting systems by understanding the business, organization and associated responsible roles
Plan and manage process development projects to address the full life cycle: requirements and policy setting
process design, documentation and training development and delivery
change management planning and deployment
and transition to an oversight system that incorporates performance monitoring and continuous improvement once the new/revised process is fully operational
Applies knowledge and understanding of global regulations in a GxP environment and produces processes and related documentation that meets regulatory requirements, supports corporate compliance, is inspection ready and is designed with operational effectiveness in mind and contains measurable controls where applicable
Identifies areas of training focus and collaborate closely with training developers on training strategies and plans
Contribute to compliance and audit/inspection readiness strategies and plans
Participate in regulatory inspections, external PV license partner audits, and other internal audits by being the liaison for documentation requests and responding to findings

Specialist IS Analyst

In this vital role, you will work as part of a Product Team focusing on the Elec...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering
Strong experience with enterprise application testing in GxP-regulated environments
Hands-on experience with CSV/CSA validation methodologies and documentation
Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing
Experience supporting enterprise platforms with issue ticketing and customer-facing support models
Proven experience in Application Support & Maintenance (AMS) for regulated systems
Experience with cloud platforms (AWS, Azure, GCP)
Incident response experience, including P1/P2 production incidents
Experience with ServiceNow, ITIL processes, and change management workflows
Ability to translate vendor capabilities and constraints into business-aligned solutions

Job Responsibility

Work as part of a Product Team focusing on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform, accelerating Amgen’s product development and commercial manufacturing
Collaborate with a dynamic, globally distributed team of technical product owners, business analysts, test/validation engineers, project managers, and scrum masters on the design, development, validation, support, and continuous optimization of Amgen Operations’ ELN ecosystem
Possess strong software development skills and rapidly translate concepts into working, production-ready solutions
Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards
Create and maintain documentation for architecture, design, validation, deployment, disaster recovery, and operations
Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms
Stay current with emerging technologies, industry best practices, and regulated system development trends
Lead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory requirements
Own and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentation
Develop and maintain test plans, test scenarios, and test scripts for system enhancements, patches, upgrades, and vendor releases

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

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

Veeva Clinical Business Administration Specialist

Empower clinical teams by optimizing the Veeva Vault systems that keep trials ru...

Location

United States , Boston

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong oral and written communication skills
excellent organizational abilities and attention to detail
ability to work both independently and collaboratively in a fast-paced environment
familiarity with clinical trial processes, ICH-GCP guidelines, and essential documents
critical thinking and problem-solving skills
proficiency in Microsoft Office applications
knowledge of GXP systems in the pharmaceutical or CRO industry, particularly CTMS or related systems
understanding of computer system validation and system lifecycles
experience with Veeva Vault Clinical eTMF and CTMS systems
database management and reporting experience

Job Responsibility

Develop and maintain Veeva Vault reports and dashboards, ensuring clear documentation for user understanding
collaborate with the Change Management team to draft system training materials, including quick reference guides and presentations
provide end-to-end user support, including troubleshooting, technical assistance, and analysis of request trends
manage business process-driven values, metadata, controlled vocabularies, and picklists
liaise with internal and external IT teams to address bugs, discuss functionality, and implement best practices
identify opportunities for process improvements and system enhancements, including performing system health checks and gathering user feedback
support PQ execution and participate in training sessions, office hours, and knowledge-sharing events
manage CTMS requests, such as study record creation, team roster updates, and troubleshooting
communicate new release information to users in an accessible and efficient manner
oversee TMF requests, including monitoring document integration metrics, conducting post-migration quality checks, and reviewing audit trails

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

Deployed GXP Specialist

Helpcare AI

Location:
United Kingdom , London

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
May 05, 2026

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