documents, risk management plans, and post-project reviews. Ensure all projects comply with industry regulations, particularly those related to pharmacovigilance and data privacy (e.g. GxP, GDPR). Coordinate and manage interactions with third-party vendors, consultants, and partners to ensure successful delivery and integration of external components or services. Support More ❯
to develop strong relationships across global teams. Experience in IT Project Management. Experience with Agile ways of working. General knowledge of the pharmaceutical setting (GXP, Validation, Privacy Concerns, ). Experience with or interest in machine learning or statistical methods. Stakeholder-facing skills to set expectations and communicate effectively. Successfully managing More ❯
hands-on experience with software implementation Proven ability to work both independently and in teams in a dynamic environment Good understanding of SaaS and GxP principles Ability to quickly understand business requirements and design creative solutions Excellent verbal and written communication skills Bachelor’s degree or equivalent relevant experience Nice More ❯
real-world evidence generation, biomarker discovery). Regulatory & Compliance Oversight: Ensure data practices adhere to FDA, EMA, GDPR, HIPAA, and industry standards (e.g., CDISC, GxP). Data Governance & Architecture: Oversee the design of robust data ecosystems, including cloud platforms (AWS/Azure), data lakes, and governance frameworks to ensure quality More ❯
as on-premise solutions. Regulatory Knowledge: Strong understanding of life sciences regulations and compliance requirements, including experience with validation processes as well as with GxP-validated systems, processes, and documentation requirements. Leadership Abilities: Proven track record of leading technical teams and managing complex projects, with excellent problem-solving and decision More ❯
3+ years of experience in Life Sciences, Healthcare, or an adjacent Safety industry Experience implementing, supporting, or administrating core business/IT operations with GxP software solutions Good knowledge of implementation methodologies for SaaS solution Proven ability to deliver on time and with a high degree of satisfaction Longstanding passion More ❯
Management), Modular Content, MLR review, and European regulatory requirements (e.g., ABPI, ANSM, AIFA) Understanding of life sciences compliance and computer systems validation requirements (e.g., GxP, GcP) Project management certification (e.g., PRINCE2, PMP) Experience with product pre-sales, solution consulting, or engagement management Fluency in Italian, French, or German SaaS/ More ❯
multidisciplinary technical oversight, including evaluation of project work, staff, methods, and procedures related to enterprise-level IT/OT systems. Compile technology documentation for GxP and critical IT technologies. Participate in system validation and testing, approve validation documentation with ITQ, and represent IT systems during audits and inspections. (40%) Consult More ❯
adhered to with handling, processing, security & privacy of data, compliant with internal security, risk management policies and practices, external regulatory and statutory requirements e.g., GxP, Sarbanes Oxley and that Tech continuity plans are in place for all business-critical products. Build relationships both internally & externally, collaborating closely with technologists and More ❯
team. Who you are: Degree in Engineering or significant technical/quality service background. Familiarity with 21 CFR Part 11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of experience in associated field. Ability to understand and interpret technical product documentation. Experience working within a More ❯
hundreds of thousands to millions in ACV Evidenced strong program leadership skills while navigating difficult periods with your delivery team(s) Delivered solutions within GxP-compliant areas Coached and mentored Engagement, Project, Program and/or Customer Success Managers who went on to do their best work due to your More ❯
resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft Office, Internet Explorer and various business More ❯
Confluence with some experience of Jira configuration. An understanding of DevOps and the associated benefits, along with an understanding of clinical trials, GCP, and GxP would also be advantageous. In addition, experience of hands-on software testing and requirements analysis would be helpful. #J-18808-Ljbffr More ❯
Quality System documents and procedures relevant to all employees (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required. Quality System documents and procedures relevant to job performance. Principal Contacts & Purpose of Contact: Internal: Global T&I More ❯
advisory roles, with significant exposure to the medical, life sciences, or pharmaceutical industry. Demonstrated knowledge of regulatory processes, medical content lifecycle, and compliance frameworks (GxP, HIPAA, ABPI, etc.). Proven experience working with or consulting on: Veeva Vault Medical Suite Salesforce (Health Cloud or Life Sciences verticals) Adobe Experience tools More ❯
advisory roles, with significant exposure to the medical, life sciences, or pharmaceutical industry. Demonstrated knowledge of regulatory processes, medical content lifecycle, and compliance frameworks (GxP, HIPAA, ABPI, etc.). Proven experience working with or consulting on: Veeva Vault Medical Suite Salesforce (Health Cloud or Life Sciences verticals) Adobe Experience tools More ❯
advisory roles, with significant exposure to the medical, life sciences, or pharmaceutical industry. Demonstrated knowledge of regulatory processes, medical content lifecycle, and compliance frameworks (GxP, HIPAA, ABPI, etc.). Proven experience working with or consulting on: Veeva Vault Medical Suite Salesforce (Health Cloud or Life Sciences verticals) Adobe Experience tools More ❯
On-Demand sector to ensure compliance with regulatory, customer and other relevant standards as applicable. Provide guidance and support the business to ensure existing GxP regulations are adhered to throughout the project for example, supporting change management and periodic reviews. Support the delivery of the Uniphar On-Demand sector quality More ❯
storage, and backup technologies. Adherence to change management and global IT policies. Strong troubleshooting skills and technical documentation discipline. Experience in regulated environments (ISO27001, GxP) is beneficial. Knowledge of IT frameworks such as ITIL, Agile methodologies; Linux knowledge is a plus. Soft Skills and Qualifications: Ability to work independently and More ❯
to 10% Nice to Have Experience in the pharmaceutical and life sciences industry Experience with Clinical, Regulatory, Quality, or Safety business processes Experience with GxP regulations and software validation process Experience with source code control systems Knowledge of AWS tools such as Lambda and EC2 Health & wellness programs Location : Remote More ❯
to 10% Nice to Have Experience in the pharmaceutical and life sciences industry Experience with Clinical, Regulatory, Quality, or Safety business processes Experience with GxP regulations and software validation process Document/Data migration experience Experience with source code control systems Amazon Web Services (AWS) tools such as Lambda and More ❯
improve existing products, services and tools. Complete all mandatory company-wide compliance training and job-specific training required for the role, including QMS, ISMS, GxP, DocuSign, SDLC as applicable. About You (Skills and Experience): A Bachelor's or higher in Computer Science, Information Systems or another related field is essential. More ❯
and adherence to global policies and procedures. Experience maintaining asset inventories. Ability to produce and follow detailed technical documentation. Experience in regulated environments (ISO27001, GxP) is beneficial. Strong troubleshooting skills and task planning abilities. Knowledge of IT frameworks such as ITIL, Kanban, Lean IT, or Agile. Knowledge of Linux is More ❯
Cambridge, England, United Kingdom Hybrid / WFH Options
Ubique Systems
advisory roles, with significant exposure to the medical, life sciences, or pharmaceutical industry. Demonstrated knowledge of regulatory processes, medical content lifecycle, and compliance frameworks (GxP, HIPAA, ABPI, etc.). Proven experience working with or consulting on: Veeva CRM for Medical Affairs (not the Sales Org) ; Veeva Vault (MedComms, PromoMats, Medical More ❯
successful in this role, you should demonstrate: Strong experience of Computer System Validation in the pharmaceutical industry. A solid understanding of validation principles and GxP regulations. Prior experience with ERP systems, including some involvement in their validation. Strong IT skills and proficiency in standard office software (e.g., Microsoft Word, Excel More ❯