Senior Manager, External QA Validation

Role: Senior Quality professional leading external validation and technology transfer activities within BioMarin’s manufacturing network. Objectives include ensuring validation lifecycle compliance, establishing quality standards, and supporting process transfers for biologics. Responsibilities: serve as SME for validation and transfer, oversee validation strategies, review GMP documentation, assess risks, and partner with internal and external teams to ensure GMP readiness. Requirements: BS in Engineering, Life Sciences, or related; 8+ years in cGMP biopharma, with extensive experience in validation, manufacturing sciences, or QA; strong understanding of global regulatory standards (FDA, EMA, ICH). Preferred: experience with biologics, external CMOs/CDMOs, and validation lifecycle management. High-Value: biologics manufacturing, process validation, technology transfer, external GMP network, global regulatory compliance, validation lifecycle oversight. WorkSetup: periodic travel required.