Associate Director, GxP Electronic Systems Quality Assurance

The Opportunity:

• Provide Global Quality oversight for GxP computerized systems, ensuring compliant implementation and lifecycle management across GMP, GCP, GLP, GVP, and GDP environments.

• Provide strategic quality eadership for Computerized System Validation (CSV) and Computer Software Assurance (CSA), including risk-based validation approaches, system changes, upgrades, integrations, data migrations, and periodic reviews.

• Lead, develop, and mentor the team, providing strategic direction and ensuring effective execution of CSV/CSA, Quality platform oversight, AI implementation, and digital compliance priorities.

• Own Quality oversight and governance of enterprise Quality digital platforms, including Veeva Vault and other GxP qualiy applications, ensuring platforms remain validated, inspection-ready, scalable, and fit for intended use.

• Establish and maintain digital Quality governance, including system ownership, change/release management, vendor oversight, access controls, audit trails, electronic records/signatures, and data integrity requirements.

• Lead Quality governance and implementation of Artificial Intelligence (AI) and emerging technologies within GxP processes, including generative AI, AI agents, machine learning, and intelligent automation.

• Develop risk-based frameworks for AI qualification, validation/assurance, change management, and ongoing monitoring in alignment with evolving regulatory expectations.

• Partner with Quality, Information Science, Clinical teams, Regulatory, Pharmacovigilance, PDM and other business functions to develop and execute the digital Quality roadmap and identify opportunities for compliant automation and process optimization.

• Serve as the Digital Systems QA SME for regulatory inspections and audits, maintaining inspection readiness and monitoring evolving FDA, EMA, PMDA, GAMP 5, 21 CFR Part 11, EU Annex 11, data integrity, CSA, and AI-related regulatory expectations.

Required Skills, Experience and Education:

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, Information Systems, or a related discipline with 10+ years of experience in pharmaceutical, biotechnology, or another regulated life sciences environment.

• Demonstrated experience in Computerized System Validation (CSV), Computer Software Assurance (CSA), and Quality oversight of GxP computerized systems across the system lifecycle.

• Strong knowledge of applicable regulations and industry guidance, including 21 CFR Part 11, EU Annex 11, GAMP 5, data integrity principles, and global GxP requirements.

• Experience providing Quality oversight for enterprise GxP platforms, cloud/SaaS applications, system implementations, upgrades, integrations, and data migrations.

• Demonstrated ability to lead cross-functional initiatives and effectively partner with Quality, IT, system owners, business process owners, and technology vendors.

Preferred Skills:

• Advanced degree in Life Sciences, Engineering, Computer Science, Information Systems, or a related discipline.

• Experience with Veeva Vault Quality Suite or comparable enterprise Quality Management platforms.

• Experience implementing or providing Quality governance for AI, generative AI, machine learning, AI agents, intelligent automation, or other emerging technologies within a regulated environment.

• Knowledge of evolving FDA, EMA, PMDA and global regulatory expectations for AI, digital technologies, cloud platforms, and risk-based computer software assurance.

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