Associate Director, Digital Quality Compliance
$164,500–$222,500 year
Remote
Job Summary
Lead the multi-year roadmap for Quality digital capabilities, defining requirements for SAP, Veeva, and LIMS systems while partnering with IT to drive prioritization and delivery of capability improvements. Serve as the primary translator between Quality and IT teams, converting complex business needs into structured functional requirements and evaluating emerging solutions to advance operational excellence. Provide business ownership for QA/QC digital systems, ensuring validated, compliant operations through standardization of processes, release planning, and change control. Support Quality data governance initiatives to enable consistent metrics and audit-ready reporting, while leading periodic reviews of system performance and compliance posture. Guide users on compliant system usage and facilitate governance forums for capability requests, applying Quality Risk Management principles to right-size validation activities.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
- 8+ years of experience in Quality or related areas within biotechnology or pharmaceutical industries
- Strong understanding of GxP Quality data domains (e.g., Quality Events/Deviations, CAPA, Change Control, Complaints, Materials Quality Management, Batch Disposition and Market Allocation and the use of metrics to monitor throughput, performance and risk)
- 5 +years experience working with SAP in a Quality context including SAP Quality Management (QM) or equivalent modules and integrations with LIMS, MES, and QMS platforms
- 7+ years of experience with Veeva Vault Quality or similar QMS technology
- Knowledge of complementary systems (e.g., ERP, LIMS, MES)
- Strong understanding of GxP Quality data domains (e.g., Quality Events/Deviations, CAPA, Change Control, Complaints)
- Experience with Quality Risk Management (ICH Q9) to drive risk-based decision-making, prioritization, and continuous improvement across GxP processes
- Experience translating complex data into clear, actionable insights for senior leaders and governance forums
- Strong written and verbal communication skills
- This role is considered Virtual
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