GxP Validation Release Readiness SME
Job Location:
Basel - Switzerland
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
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.
Required Skills:
Key Performance Indicators: Overall change effectiveness measures. Business value capture from key programs. Quality of relationships with relevant leaders and team. Graduate or postgraduate degree; Coaching or psychology background desirable; Further education change management organizational development; 5 years experience driving organizational change projects; Experience in the Pharmaceutical industry; Strong written and verbal communication skills as well as solid presentation skills; Flexible and adaptable; able to work in ambiguous situations; A highly organized energetic and creative change professional; Must be a team player and able to work collaboratively with and through others; Ability to influence others (Sr. leadership) and move toward a common vision or goal.
