OPC UA, MQTT, REST/SOAP APIs, SQL, Python, etc. Familiarity with lab automation platforms (e.g., Tecan, Hamilton, Agilent, Beckman, Sartorius) and related data workflows. A good understanding of GxP, 21 CFR Part 11, data integrity principles, and validated environments is a plus. Every day, Lonza's products and services have a positive impact on millions of people. For us More ❯
Kubernetes) in research environments. Familiarity with infrastructure considerations (networking, hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model delivering architecture capability across product. More ❯
Experience with OT systems including operational technology, OT-IT integration and relevant protocols. Strong technical expertise in OT environments with practical knowledge of operational processes and infrastructure. Familiarity with GxP requirements and regulations for OT systems. Proven leadership qualities, empathy and a solutions and teamwork centered approach. The role requires hands-on experience with OT systems and operational processes in More ❯
exposure to clinical trials. Clinical, pharmacological, and therapeutic knowledge in neuroscience. Good understanding of clinical study design principles and basic familiarity working with clinical data in a clinical trial (GxP) setting. Strong knowledge and understanding of (multivariate implementations of) statistical methods such as time to event analysis, machine learning, meta-analysis, mixed effect modelling, longitudinal modelling, Bayesian methods, variable selection More ❯
or technical) of people for a full lifecycle implementation. Experience of using and (ideally) developing methods and process to ensure structured delivery of IT project in a regulated (ideally GxP/CSV) environment, i.e. using stage gates, quality controls, code reviews, planning and delivering testing Relevant academic and vocational qualifications such as Prince 2/PMP desirable Additional Information: Occasional More ❯
provide regular status updates to stakeholders Collaborate with internal teams to ensure alignment with client expectations and industry standards Maintain accurate records and documentation in line with SOPs and GxP requirements Represent docs24 at industry events, conferences, and client meetings to promote our capabilities and build relationships Required Experience & Skills Proven experience in existing business development, account management, or client More ❯
technical teams. Structured, proactive, and able to work independently as the "go-to" person for data. Industry Requirement Pharmaceutical industry experience is mandatory. Experience working in a regulated environment (GxP, CSV compliance) preferred. What We Offer Fully remote engagement (global team). Long-term contract with high client visibility. Opportunity to lead significant data workstreams in a major pharma program. More ❯
Bala Cynwyd, Pennsylvania, United States Hybrid / WFH Options
Larimar Therapeutics
year undergraduate degree 10+ years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with Health Canada, EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies. Knowledge of eCTD More ❯
Hatfield, England, United Kingdom Hybrid / WFH Options
Cpl Life Sciences
a strong emphasis on stakeholder management and effective communication with senior managers and directors. What are we looking for? Experience delivering business changes or IT business system projects to GxP environment, either in a pharma site or equivalent a must have Demonstrated experience in IT Project Management. Demonstrated experience in stakeholder management and presenting to senior managers and directors. Experience More ❯
Engineering, Life Sciences, or a related domain. Familiarity with regulatory frameworks including GAMP and other relevant standards. Experience working with both custom and off-the-shelf platforms in regulated (GxP) environments-such as in manufacturing, quality control, or clinical settings. Strong written documentation and stakeholder engagement skills. Confidence working across departments and communicating with both technical and non-technical audiences. More ❯
Engineering, Life Sciences, or a related domain. Familiarity with regulatory frameworks including GAMP and other relevant standards. Experience working with both custom and off-the-shelf platforms in regulated (GxP) environments-such as in manufacturing, quality control, or clinical settings. Strong written documentation and stakeholder engagement skills. Confidence working across departments and communicating with both technical and non-technical audiences. More ❯
NIST, AI Governance, CIS etc. • Good compliance understanding of industry domains such as BFSI – (SOX, FFIEC, PCI-DSS, BASEL, MAS etc.), Healthcare & Life-sciences – (HIPAA, Hi-Trust, FDA CFR, GxP Compliance), Telecom, Retail, Data Privacy (GDPR, CCPA) Energy & Utilities (NERC, FERC) Information Security (ISO 27000, NIST, CIS) TPRM • Business Resiliency & Cyber Recovery, ZTA • GRC Project & Program Management • Excellent written and More ❯
NIST, AI Governance, CIS etc. • Good compliance understanding of industry domains such as BFSI – (SOX, FFIEC, PCI-DSS, BASEL, MAS etc.), Healthcare & Life-sciences – (HIPAA, Hi-Trust, FDA CFR, GxP Compliance), Telecom, Retail, Data Privacy (GDPR, CCPA) Energy & Utilities (NERC, FERC) Information Security (ISO 27000, NIST, CIS) TPRM • Business Resiliency & Cyber Recovery, ZTA • GRC Project & Program Management • Excellent written and More ❯
NIST, AI Governance, CIS etc. • Good compliance understanding of industry domains such as BFSI – (SOX, FFIEC, PCI-DSS, BASEL, MAS etc.), Healthcare & Life-sciences – (HIPAA, Hi-Trust, FDA CFR, GxP Compliance), Telecom, Retail, Data Privacy (GDPR, CCPA) Energy & Utilities (NERC, FERC) Information Security (ISO 27000, NIST, CIS) TPRM • Business Resiliency & Cyber Recovery, ZTA • GRC Project & Program Management • Excellent written and More ❯
london (city of london), south east england, united kingdom
HCLTech
NIST, AI Governance, CIS etc. • Good compliance understanding of industry domains such as BFSI – (SOX, FFIEC, PCI-DSS, BASEL, MAS etc.), Healthcare & Life-sciences – (HIPAA, Hi-Trust, FDA CFR, GxP Compliance), Telecom, Retail, Data Privacy (GDPR, CCPA) Energy & Utilities (NERC, FERC) Information Security (ISO 27000, NIST, CIS) TPRM • Business Resiliency & Cyber Recovery, ZTA • GRC Project & Program Management • Excellent written and More ❯
NIST, AI Governance, CIS etc. • Good compliance understanding of industry domains such as BFSI – (SOX, FFIEC, PCI-DSS, BASEL, MAS etc.), Healthcare & Life-sciences – (HIPAA, Hi-Trust, FDA CFR, GxP Compliance), Telecom, Retail, Data Privacy (GDPR, CCPA) Energy & Utilities (NERC, FERC) Information Security (ISO 27000, NIST, CIS) TPRM • Business Resiliency & Cyber Recovery, ZTA • GRC Project & Program Management • Excellent written and More ❯
meet regulatory standards and align with architectural best practices. Key Responsibilities: Build and optimise scalable data pipelines using Databricks and Apache Spark (PySpark). Ensure performance, scalability, and compliance (GxP and other standards). Collaborate on requirements, design, and backlog refinement. Promote engineering best practices including CI/CD, code reviews, and testing. Research and introduce new tools, technologies, and More ❯
meet regulatory standards and align with architectural best practices. Key Responsibilities: Build and optimise scalable data pipelines using Databricks and Apache Spark (PySpark). Ensure performance, scalability, and compliance (GxP and other standards). Collaborate on requirements, design, and backlog refinement. Promote engineering best practices including CI/CD, code reviews, and testing. Research and introduce new tools, technologies, and More ❯
meet regulatory standards and align with architectural best practices. Key Responsibilities: Build and optimise scalable data pipelines using Databricks and Apache Spark (PySpark). Ensure performance, scalability, and compliance (GxP and other standards). Collaborate on requirements, design, and backlog refinement. Promote engineering best practices including CI/CD, code reviews, and testing. Research and introduce new tools, technologies, and More ❯
meet regulatory standards and align with architectural best practices. Key Responsibilities: Build and optimise scalable data pipelines using Databricks and Apache Spark (PySpark). Ensure performance, scalability, and compliance (GxP and other standards). Collaborate on requirements, design, and backlog refinement. Promote engineering best practices including CI/CD, code reviews, and testing. Research and introduce new tools, technologies, and More ❯
london (city of london), south east england, united kingdom
Fimador
meet regulatory standards and align with architectural best practices. Key Responsibilities: Build and optimise scalable data pipelines using Databricks and Apache Spark (PySpark). Ensure performance, scalability, and compliance (GxP and other standards). Collaborate on requirements, design, and backlog refinement. Promote engineering best practices including CI/CD, code reviews, and testing. Research and introduce new tools, technologies, and More ❯
controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition. The QA officer is expected to identify, escalate and work to address any GMP/GxP issues with potential impact to product quality or quality compliance. Together we offer fantastic opportunities for committed employees to learn and develop their career with us. At Piramal , we research … the relevant disposition of products. Where potential issues exist, these are to be highlighted to the QA manager. Promote and work to ensure compliance with all relevant GMP/GxP requirements. Support and lead as required, quality process improvements and quality management system improvements within the department and on site. Escalate any identified GMP/GxP areas of concern to More ❯
compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems. As a CSV Specialist your responsibilities will include, although not limited to: Leading and executing validation activities for new and existing computerised systems, including both bespoke and COTS … solutions, in accordance with GAMP 5 principles. Performing risk assessments to define the appropriate validation strategy and documentation scope, aligned with the organisation’s overall GxP risk stratification framework. Preparing and maintaining validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), validation plans, protocols, reports, and traceability matrices. Working collaboratively with IT, QA, system owners, and vendors to ensure … compliant manner. Providing support during audits and regulatory inspections, addressing data integrity and CSV-related queries. Ensuring all system lifecycle documentation is maintained in accordance with internal SOPs and GxP standards. Assisting in developing implementing and testing disaster recovery plans for key computerised systems in collaboration with business departments. Contributing to the continuous improvement of CSV procedures, templates, and best More ❯
compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems. As a CSV Specialist your responsibilities will include, although not limited to: Leading and executing validation activities for new and existing computerised systems, including both bespoke and COTS … solutions, in accordance with GAMP 5 principles. Performing risk assessments to define the appropriate validation strategy and documentation scope, aligned with the organisation’s overall GxP risk stratification framework. Preparing and maintaining validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), validation plans, protocols, reports, and traceability matrices. Working collaboratively with IT, QA, system owners, and vendors to ensure … compliant manner. Providing support during audits and regulatory inspections, addressing data integrity and CSV-related queries. Ensuring all system lifecycle documentation is maintained in accordance with internal SOPs and GxP standards. Assisting in developing implementing and testing disaster recovery plans for key computerised systems in collaboration with business departments. Contributing to the continuous improvement of CSV procedures, templates, and best More ❯
