Associate Director, IT GxP & Quality Systems

Winston-Salem, North Carolina, United States

The Associate Director, IT GxP & Quality Systems, leads strategic programs within the Company's regulated technology landscape and serves as the primary technology partner for Quality Systems. This role is accountable for the delivery, governance, optimization, compliance, and lifecycle management of GxP technology platforms, with primary ownership of the Quality Management Systems (QMS) environment.

The role drives technology solutions that enable compliant business processes across Quality, Clinical, Regulatory, Manufacturing, Technical Operations, and other GxP-regulated functions. The Associate Director connects technology execution with departmental strategy, ensuring systems scale effectively to support the organization's evolving clinical, manufacturing, and commercialization needs. The role leads cross-functional initiatives, manages external partners, and continuously improves Quality Systems capabilities while maintaining regulatory compliance and inspection readiness.

The Associate Director level is characterized by leading programs with strategic impact, driving outcomes at scale, and connecting execution to departmental strategy with emphasis to transform processes to support commercialization.

Key Responsibilities:

GxP & Quality Systems Leadership

• Lead the Enterprise GxP and Quality Systems portfolio, including strategy execution, governance, delivery, operations, support, and lifecycle management.
• Own the Quality Management Systems environment, including roadmap execution, enhancements, integrations, system administration, and ongoing optimization.
• Drive process harmonization, automation, continuous improvement initiatives, and future-state Quality Systems.
• Lead strategic technology programs supporting Quality, Clinical, Manufacturing, Regulatory, and Technical Operations functions
• Oversee implementation, enhancement, integration, validation, release, and support activities across the GxP application portfolio.
• Manage technology priorities, roadmaps, vendor deliverables, and system lifecycle activities to ensure reliable business operations.
• Partner with business stakeholders to translate operational requirements into scalable and compliant technology solutions.
• Recommend technology improvements and business process enhancements that improve efficiency, compliance, and user experience.

Compliance & Validation

• Ensure compliance with applicable GxP regulations, including FDA 21 CFR Part 11, EU Annex 11, data integrity requirements, and CSV/CSA expectations.
• Lead validation activities including requirements management, risk assessments, testing strategy, traceability, validation documentation, and release readiness.
• Maintain inspection readiness across the Quality Systems landscape and support regulatory inspections, audits, and compliance assessments.
• Establish appropriate governance, system controls, audit trail requirements, electronic signature controls, user access structures, and data ownership standards.

Cross-Functional Leadership

• Lead cross-functional teams and strategic initiatives involving Quality, Clinical, Regulatory, Manufacturing, and Information Technology stakeholders.
• Influence decision-making using subject matter expertise in Quality Systems, compliance, validation, and regulated technology environments. Associate Director roles are expected to provide discipline leadership and drive strategic outcomes within their specialized area.
• Coordinate priorities across functional partners to ensure alignment between business objectives and technology delivery.
• Coach project teams and technology partners on Quality Systems best practices, compliance expectations, and governance standards.
• Manage…