Associate Director, Computer System Compliance

Requirements

• 5+ years validation systems using Computer System Assurance methodologies including Agile and Waterfall approaches.
• 7+ years in software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation/ computer system assurance with at least 2 years focused on AI/ML or Advanced Analytics.
• Experience in at least one of the following manufacturing, facilities, process, laboratory method or cleaning validation.
• Experience with managing enterprise demand and aligning 3rd party validation service providers.
• Experience implementing Validation Management Tools and Automated testing tools.
• Experience validating systems on AWS, Azure, or GCP (specifically SageMaker or Vertex AI and basic understanding of Python, R, or SQL to audit automated testing scripts and data pipelines.)
• Previous experience validating GxP systems not limited to Rockwell DCS, Empower CDS, Thermo Fisher LIMS, MODA for Environmental Monitoring, Biovia LES/ELN, Maximo CMMS, MES Systems.
• Expert in GAMP 5 (including 2nd Edition), 21 CFR Part 11, and EudraLex Annex 11.
• Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
• Experience in managing small to medium-sized projects and outside vendors.
• Effective written and verbal communications skills.

Benefits

• Medical, Dental, Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness