Associate Director, E2E CSV/C&Q

Coopers Group; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Coopers Group in Basel, Switzerland seeks a professional to lead the validation strategy for an integrated CSV/CSA solution within a GMP environment. The role focuses on defining use cases, boundaries, and validation principles across diverse source systems and platforms.

The candidate should have strong IT/OT experience, data integrity knowledge, and the ability to coordinate cross-functional teams including Business, Quality, IT, OT and external partners.

Qualifikationen

• Must have experience developing end-to-end validation strategies for GxP systems.
• Strong knowledge of ALCOA+, data integrity, and risk-based validation.
• Experience in IT/OT environments including MES, historians, and integration platforms.
• Ability to align Business, Quality, IT, OT, Engineering and partners.

Aufgaben

• Develop and maintain a modular CSV/CQ validation strategy for a connected manufacturing data solution.
• Define use cases, GxP boundaries, system classifications and validation principles across source systems.
• Establish reusable validation framework for initial implementation and future deployments.
• Coordinate qualification activities for production deployment across multiple stakeholders.
• Ensure traceability, testing coverage, validation evidence, data integrity and release readiness.
• Coordinate validation deliverables with Business, Engineering, Automation, IT, OT, Quality and partners.
• Define qualification approaches for batch traceability, process monitoring and data sharing.
• Assess data lineage, transformations, interfaces, access controls and data-integrity risks.

Kenntnisse

GxP validation

Data integrity

Risk-based validation

IT/OT environments

Requirements management

Traceability matrices

ALCOA+ principles

Stakeholder alignment

Ausbildung

Bachelor’s or Master’s degree in Engineering/CS/IT/Life Sciences/QA

Jobbeschreibung

Hard Facts

• Start Date: 1 November 2026
• Duration: 12 months
• Workload: 100%, 41 hours per week
• Location: Basel, Switzerland
• Contract Type: Temporary contract assignment
• Language: Business-fluent English

Your Responsibilities

• Develop and maintain an integrated, modular and risk-based CSV/C&Q strategy for a connected manufacturing data solution.
• Define intended use, GxP boundaries, system classifications and validation principles across source systems, integrations, platform services, data products and operational applications.
• Establish a reusable validation framework for the initial implementation and future deployments.
• Coordinate qualification and validation activities required for production deployment.
• Ensure complete requirements traceability, testing coverage, validation evidence, data integrity and release readiness across the end-to-end solution.
• Coordinate validation deliverables across Business, Engineering, Automation, IT, OT, Quality and external partners.
• Define the qualification approach for operational applications such as batch traceability, process monitoring and controlled data sharing.
• Assess data lineage, transformations, interfaces, auditability, access controls and data-integrity risks across connected systems.
• Ensure compliance with ALCOA+ principles and applicable GxP requirements.
• Define supplier-assurance and testing-reliance strategies for technology providers and implementation partners.
• Ensure that validation deliverables are complete, internally consistent and ready for Quality review.
• Embed validated-state maintenance requirements into the future operating model.
• Develop reusable qualification archetypes, minimum validation deliverables and validation prerequisites for future deployments.
• Facilitate risk assessments, intended-use evaluations and validation decisions across multiple workstreams.
• Proactively manage and **escalate** validation risks, dependencies and issues.
• Establish a pragmatic and defensible validation approach without unnecessary documentation or duplicated testing.

Your Profile

• Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, Pharmaceutical Sciences, Quality Management or a related discipline.
• Proven experience developing and coordinating end-to-end validation strategies for integrated GxP systems.
• Strong pharmaceutical or biopharmaceutical industry experience.
• Broad understanding of IT and OT environments, including automation, MES, historians, infrastructure, integration platforms and enterprise applications.
• Experience validating data flows, transformations, interfaces, contextualisation logic, data products and software applications used in regulated operations.
• Strong knowledge of intended use, GxP impact assessment, system criticality and risk-based validation.
• Practical experience with requirements management, traceability matrices, risk assessments, test strategies and controlled validation documentation.
• Strong understanding of data integrity, ALCOA+, data lineage, auditability and access controls.
• Experience assessing supplier capabilities and leveraging vendor documentation and testing appropriately.
• Strong knowledge of GMP, CSV/CSA, C&Q, change control, deviations, CAPA and validated-state maintenance.
• Demonstrated ability to align Business, Quality, IT, OT, Engineering, system owners and external partners.
• Business-fluent English.
• A pragmatic approach to compliance, with the ability to establish proportionate controls and avoid unnecessary requalification.