Director, QA Validation & Computer Systems Assurance

Role: Director of QA Validation at a biopharma manufacturing site, overseeing validation and computer systems assurance (CSA) for highly automated, digitally integrated processes. Objectives include maintaining validated states across GMP manufacturing, ensuring compliance with FDA/EMA guidance, and representing validation programs during regulatory inspections. Responsibilities encompass managing validation lifecycle documentation, risk-based qualification programs, GxP data integrity, vendor assessments, and integration of CSA into manufacturing systems and digital initiatives. Leading a team of validation scientists and engineers, developing budgets, and aligning validation strategies with site and enterprise priorities are key aspects. The role also involves ensuring audit readiness and maintaining compliance with evolving regulatory standards.

Qualifications: BS/BA in Engineering, Computer Science, or Life Sciences; 12+ years in pharmaceutical/biopharma manufacturing, including 7+ years in validation or QA roles; 5+ years managing teams in GxP environments. Deep knowledge of validation methodologies (GAMP 5, FDA CSA guidance 2022, 21 CFR Part 11, EU Annex 11), and experience with GxP-related automated systems such as MES, DCS/SCADA, LIMS, and ERP systems. Prior experience with regulatory inspections is preferred.

High-Value Details: Focus on biologics manufacturing, validation of automated systems, with an emphasis on data integrity and regulatory compliance. The position is based in Saratoga Springs, NY, with a Monday-Friday schedule, and involves collaboration with IT, automation, manufacturing engineering, and regulatory teams.