Senior Manager, Global R&D Audits & Inspections Readiness

Role: Senior Manager, Global R&D Audits & Inspections Readiness at a biopharma company focused on cancer therapies, ensuring regulatory compliance and inspection preparedness of R&D technology systems. Responsibilities: lead validation-by-design activities integrating GxP, CSV, and CSA principles into Agile delivery; coordinate audit and inspection readiness including evidence preparation, mock audits, and real inspections; oversee compliance of externally sourced systems and vendors; translate regulatory expectations (FDA 21 CFR Part 11, EMA Annex 11, GAMP 5, ALCOA+) into technical actions; manage CAPA, remediation, and risk logs; collaborate across Quality, Compliance, IT, and R&D teams; provide technical and regulatory guidance during audits; support continuous quality initiatives and metrics reporting. Qualifications: Bachelor’s degree in Computer Science, Life Sciences, or related, with 7+ years in IT compliance, quality assurance, validation, or audit roles within pharma/biotech; 3+ years supporting audit readiness and validation programs; expertise in GxP, CSV, CSA, data integrity, and regulated R&D environments; strong knowledge of relevant regulations and modern software delivery (cloud, SaaS, AI/ML). Preferred certifications include CQA, CISA, ScrumMaster. Skills: risk-based thinking, cross-functional collaboration, documentation discipline, inspection prowess, vendor assessment, and project management in Agile/DevOps contexts. Travel required. Location flexible with some travel expected.