Drive and implement sustainable digital validation system strategies in collaboration with global teams across Roche and affiliates.
Optimize and build Qualification/Validation business processes, create and maintain validation documentation standards.
Collaborate with cross-functional experts and leaders, including Quality, Manufacturing, Engineering, and IT.
Act as a primary thought partner to senior management, translating complex technical validation challenges into actionable strategic insights.
Spearhead enterprise-wide change management and training programs.
Translate the aligned business processes into master data and manage the end-to-end lifecycle of master data within the Validation System.
Lead risk assessment initiatives to proactively identify system compliance issues and architect robust mitigation plans.

Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical field is preferred.
10+ years of experience in the pharmaceutical or biotechnology industry, with a focus on process development, manufacturing operations, or validation.
Proven track record in matrix leadership, cross-functional team management, or direct people management.
Knowledge of FDA (CFRs), EMA, and ICH regulations, specifically regarding 21 CFR Part 11 compliant GMP environments.
Advanced proficiency in qualification and validation business processes, risk assessments, and technical documentation.
Experience with ValGenesis or similar Validation Lifecycle Management Systems (VLMS) is highly preferred.
Demonstrated ability to lead enterprise-level projects from requirements analysis through to system design and implementation.

A discretionary annual bonus may be available based on individual and Company performance.

Validation System Business Process Owner – BPO

Key skills