To support our global IT initiatives within a regulated pharmaceutical environment we are looking for an experienced IT ServiceNow Compliance & Validation Lead. In this role you will be responsible for ensuring that the ServiceNow platform is qualified validated and maintained in a GxP-compliant manner while acting as the bridge between IT Quality Assurance and business stakeholders.
Frame Conditions:
- Location: Remote
- Contract type: Freelance (full-time assignment)
- Industry: Pharmaceutical / Life Sciences
- Duration: 12 months
- Note: Only candidates located within the EU can be considered.
Tasks
- Develop and execute the compliance and validation strategy for the ServiceNow platform in a regulated environment.
- Lead the Computer System Validation (CSV) lifecycle for ServiceNow modules used in GxP processes.
- Create maintain and review validation documentation (Validation Plans Risk Assessments URS IQ/OQ/PQ Traceability Matrices).
- Define and enforce GxP controls audit trails and data integrity principles (ALCOA).
- Support system reviews revalidation activities and change control processes.
- Act as IT lead during audits and regulatory inspections.
- Collaborate closely with QA IT Security Business Process Owners and ServiceNow developers.
- Provide training and ensure SOPs and Work Instructions are up to date.
Requirements
- 5 years of IT compliance/validation experience in the pharmaceutical or life sciences industry.
- 3 years working with ServiceNow in a regulated (GxP) environment.
- Strong knowledge of GxP compliance frameworks and guidelines (e.g. 21 CFR Part 11 EU Annex 11 GAMP 5 and ALCOA).
- Proven expertise in Computer System Validation (CSV) and SDLC processes.
- Familiarity with ITIL processes (Change Incident Problem Management).
- Excellent documentation communication and stakeholder management skills.
- Experience with validated SaaS platforms and vendor qualification processes is a plus.
- Fluency in English required.
Preferred Certifications (nice-to-have):
- ServiceNow Certified System Administrator / Implementation Specialist
- GAMP 5 or CSV-related certifications
- ITIL Foundation Certification
- Project Management Certification (PMP PRINCE2)
To support our global IT initiatives within a regulated pharmaceutical environment we are looking for an experienced IT ServiceNow Compliance & Validation Lead. In this role you will be responsible for ensuring that the ServiceNow platform is qualified validated and maintained in a GxP-compliant man...
To support our global IT initiatives within a regulated pharmaceutical environment we are looking for an experienced IT ServiceNow Compliance & Validation Lead. In this role you will be responsible for ensuring that the ServiceNow platform is qualified validated and maintained in a GxP-compliant manner while acting as the bridge between IT Quality Assurance and business stakeholders.
Frame Conditions:
- Location: Remote
- Contract type: Freelance (full-time assignment)
- Industry: Pharmaceutical / Life Sciences
- Duration: 12 months
- Note: Only candidates located within the EU can be considered.
Tasks
- Develop and execute the compliance and validation strategy for the ServiceNow platform in a regulated environment.
- Lead the Computer System Validation (CSV) lifecycle for ServiceNow modules used in GxP processes.
- Create maintain and review validation documentation (Validation Plans Risk Assessments URS IQ/OQ/PQ Traceability Matrices).
- Define and enforce GxP controls audit trails and data integrity principles (ALCOA).
- Support system reviews revalidation activities and change control processes.
- Act as IT lead during audits and regulatory inspections.
- Collaborate closely with QA IT Security Business Process Owners and ServiceNow developers.
- Provide training and ensure SOPs and Work Instructions are up to date.
Requirements
- 5 years of IT compliance/validation experience in the pharmaceutical or life sciences industry.
- 3 years working with ServiceNow in a regulated (GxP) environment.
- Strong knowledge of GxP compliance frameworks and guidelines (e.g. 21 CFR Part 11 EU Annex 11 GAMP 5 and ALCOA).
- Proven expertise in Computer System Validation (CSV) and SDLC processes.
- Familiarity with ITIL processes (Change Incident Problem Management).
- Excellent documentation communication and stakeholder management skills.
- Experience with validated SaaS platforms and vendor qualification processes is a plus.
- Fluency in English required.
Preferred Certifications (nice-to-have):
- ServiceNow Certified System Administrator / Implementation Specialist
- GAMP 5 or CSV-related certifications
- ITIL Foundation Certification
- Project Management Certification (PMP PRINCE2)
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