collaboration and change leadership skills Expertise in digital product lifecycle, from experimentation to scale Experience supporting regulatory audits and inspections involving emerging technologies, including AI and automation, in a GxP or highly regulated environment Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of More ❯
Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Excellent interpersonal and communication skills, both written More ❯
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 ❯
Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator Ability to effectively interface with CROs and software vendor Previous experience working in clinical trials, with emphasis on GxP and compliance Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator ~ Ability to effectively interface with CROs and software vendor ~ Previous experience working in clinical trials, with emphasis on GxP and compliance ~ Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management ~ Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator ~ Ability to effectively interface with CROs and software vendor ~ Previous experience working in clinical trials, with emphasis on GxP and compliance ~ Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management ~ Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator ~ Ability to effectively interface with CROs and software vendor ~ Previous experience working in clinical trials, with emphasis on GxP and compliance ~ Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management ~ Quality driven with a focus on attention More ❯
Veeva Clinical Vault as an end user, business, or system administrator ~ Ability to effectively interface with CROs and software vendor ~ Previous experience working in clinical trials, with emphasis on GxP and compliance ~ Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management ~ Quality driven with a focus on attention 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 ❯
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 ❯
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 ❯
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 ❯
