Associate Director, End‑to‑End CSV/C&Q

About the role

We are seeking an experienced Associate Director to lead the end‑to‑end Computerised System Validation (CSV) and Qualification (C&Q) strategy for a connected manufacturing data solution. This senior, cross‑functional assignment combines deep pharmaceutical validation expertise with a broad understanding of IT, OT, automation and manufacturing data platforms.

Key responsibilities

• Develop and maintain a modular, risk‑based CSV/C&Q strategy covering source systems, integrations, platform services and operational applications.
• Define intended use, GxP boundaries, system classifications and validation principles across the solution.
• Establish a reusable validation framework for initial implementation and future deployments.
• Coordinate qualification and validation activities, ensuring traceability, testing coverage, data integrity and release readiness.
• Collaborate with Business, Engineering, Automation, IT, OT, Quality and external partners to deliver complete validation documentation.

Required profile

• Bachelor’s or Master’s degree in Engineering, Computer Science, Life Sciences or related field.
• Proven experience developing end‑to‑end validation strategies for integrated GxP systems in the pharmaceutical or biopharmaceutical industry.
• Broad understanding of IT/OT environments, including MES, automation, historians and integration platforms.
• Strong knowledge of GxP impact assessment, risk‑based validation and ALCOA+ data‑integrity principles.
• Business‑fluent English and ability to align multiple stakeholders.

Required skills

• Computerised System Validation (CSV) and Qualification (C&Q)
• GxP regulations and ALCOA+ data integrity
• Risk assessment and traceability matrix creation
• MES, automation and OT integration
• Requirements management and test strategy development