Operational Excellence & IT Compliance Lead

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Branchburg, NJ, US

6 days ago Requisition

Salary Range: $ To $ Annually

Operational Excellence & IT Compliance Lead

Job Description

Position Brand

Description:

This position is responsible for delivering, maintaining, and supporting products and solutions in a way that drives business value while ensuring alignment with GxP requirements, data integrity principles and regulatory expectations. The IT Compliance analyst helps enable business effectiveness by identifying opportunities across business areas for leveraging technology, process, and information while maintaining or improving compliance. The IT compliance analyst identifies systems requirements and recommends appropriate compliance strategies for delivering changes to systems, new systems, or retirement of systems.

They serve as thought leader, influence evolution of internal standards, adoption of compliance strategies and frameworks, enhancement of existing processes, and drive process changes. This role will collaborate with Branchburg and HQ IT teams to meet goals for both current and anticipated future needs for new and existing technologies, practices and initiatives.

Site Operational Excellence Leadership

• Lead the site Operational Excellence strategy, governance model, and continuous improvement roadmap in alignment with business priorities, quality expectations, and site performance objectives.
• Establish and sustain a culture of continuous improvement by engaging leaders and employees in problem solving, standard work, visual management, and performance management practices.
• Partner with site leadership to identify, prioritize, and execute improvement opportunities that increase compliance, efficiency, reliability, and business value.
• Define and monitor site-level Operational Excellence metrics, improvement initiatives, and benefits realization to ensure measurable and sustainable outcomes.

IT Compliance Oversight & Governance

• Provide leadership oversight for IT Compliance activities supporting GxP computerized systems across the system lifecycle.
• Ensure compliance with internal SOPs, data integrity principles, 21 CFR Part 11 expectations, and applicable regulatory standards including FDA, EMA, and GAMP 5 guidance.
• Serve as a site-level quality and compliance partner for validation strategy, lifecycle controls, inspection readiness, and risk-based decision making.
• Influence the evolution of site and global standards, compliance frameworks, and operating practices to support current and future business needs.

Operational Excellence Program Execution

• Lead cross-functional improvement initiatives using structured problem-solving, Lean, Six Sigma, root cause analysis, and change management practices as appropriate.
• Coach teams in identifying process waste, variation, compliance risk, and performance gaps, and guide teams toward practical, sustainable solutions.
• Facilitate governance forums, workshops, and performance reviews to align stakeholders, remove barriers, and maintain momentum on priority initiatives.
• Promote standardization of processes, tools, and operating rhythms across the site to support reliable execution and scalability.

System Lifecycle Compliance

• Ensure IT systems remain in a validated and compliant state throughout the lifecycle, including implementation, operation, change, periodic review, and retirement.
• Provide oversight for change control, incident/problem management, CAPA management, periodic reviews, access reviews, and system retirement activities.
• Confirm system changes meet validation, testing, documentation, approval, and closure requirements before release or implementation.
• Prevent unauthorized or uncontrolled changes that may impact GxP processes, data integrity, or business continuity.

Risk Management, Audit Readiness & Remediation

• Lead or approve system risk assessments, regulatory classifications, and control strategies for GxP computerized systems.
• Represent IT Compliance and validation topics during internal audits,…