GxP Validation / Release Readiness SME
Temporär
Next-Link
Overview
We are looking for a senior GxP Validation / Release Readiness specialist to provide independent advisory support across validation, testing, deployment, cutover, go-live and hypercare activities for a major pharmaceutical regulatory transformation.
Key Responsibilities
- Provide independent assessment of validation readiness.
- Assess GxP and pharmaceutical technology quality considerations.
- Review testing, validation and deployment dependencies.
- Identify validation and compliance risks.
- Assess readiness across Business, IT, System Integrators, data and technology workstreams.
- Identify critical gaps ahead of deployment.
- Support cutover-readiness assessments.
- Assess go-live readiness and key deployment risks.
- Provide recommendations around unresolved risks and dependencies.
- Support hypercare and stabilisation assessments.
- Assess change impacts relating to quality, validation and deployment.
- Produce clear assessment and decision-support materials for governance forums.
- Support coordination of validation, quality and readiness inputs.
Requirements
Essential Experience
- Strong experience in GxP-regulated pharmaceutical environments.
- Significant pharmaceutical validation experience.
- Experience with complex technology transformation programmes.
- Experience with testing and validation of enterprise systems.
- Experience with release readiness and deployment.
- Experience with cutover and go-live.
- Experience assessing business and technology readiness.
- Strong understanding of pharmaceutical technology quality requirements.
- Experience identifying risks, dependencies and readiness gaps.
- Ability to communicate effectively with senior Business and IT stakeholders.
Desirable
- Veeva Vault / Veeva Vault RIM experience.
- Regulatory transformation experience.
- Previous Novartis experience.
- Freeway or comparable regulatory-platform transformation.
- Experience with large-scale data migration and validation.
On-site Requirement
Must be available for Basel attendance during validation, cutover and go-live phases.
Ideal Background
Senior CSV/GxP Consultant / Validation Lead / Quality Technology SME / Release Readiness Lead / GxP Transformation Consultant.
Die Stellenanzeige wurde vor Vor 2 Tagen veröffentlicht
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