Director, Global Product Labeling

Leadership, Visibility & Quality Ownership

• Lead the GPLO function with a quality first mindset, ensuring clear ownership, robust process adherence, and proactive issue identification and escalation.
• Act as a visible operational leader who role models accountability, transparent communication, and cross functional partnership.
• Set the tone for high performance and continuous improvement, driving clarity, consistency, and compliance across all labeling operations.

Operational Excellence & End to End Labeling Quality

• Oversee the entire labeling workflow to ensure right first time creation, revision, and management of printed labeling materials.
• Maintain and continuously improve controlled records, audit trails, and traceability for historical and current labeling changes.
• Ensure global labeling processes meet regulatory, quality, and internal governance standards at all times.
• Lead GPLO representation in Quality Management System (QMS) processes, including change control, deviations, CAPAs, and SOP governance.

Cross Functional Leadership & Strategic Influence

• Serve as the primary operational interface between GPLO and Quality, GRADS, Technical Operations, Supply Chain.
• Provide expert interpretation of regulatory and policy requirements, and ensure global alignment on labeling execution.
• Influence and partner with senior stakeholders to drive strategic improvements in labeling systems, templates, and processes.

Inspection Readiness & Risk Management

• Lead from the front in preparing the organization for audits and inspections, ensuring GPLO processes and documentation are consistently inspection ready.
• Anticipate and manage labeling risks proactively by implementing early visibility mechanisms, dashboards, and quality controls.
• Support root cause investigations and CAPA development, ensuring sustainable and systemic corrective actions.

Process Improvement & Efficiency

• Identify, design, and implement scalable process improvements that reduce complexity, improve cycle times, and enhance operational predictability.
• Build and maintain standardized global operating procedures, templates, and best practices.
• Leverage data and metrics to deliver clear, actionable insights to senior leadership, increasing transparency and accountability.

Team Leadership, Development & Culture

• Build a high performing team through coaching, development, and role clarity, ensuring GPLO operates with strong technical skill and leadership maturity.
• Foster a team culture grounded in quality, transparency, ownership, and continuous learning.
• Ensure team members have the capabilities, tools, and support they need to execute at a high standard.

Required Knowledge, Skills, and Abilities

• Demonstrated ability to lead from the front with strong operational judgment, strategic thinking, and a proactive approach to problem solving.
• Proven track record of ensuring quality at source, including quality control, documentation excellence, and regulatory compliance.
• Strong ability to create visibility through metrics, dashboards, and structured reporting.
• Deep experience in global regulatory labeling, operations, or related regulatory functions.
• Exceptional collaboration skills, with the ability to influence senior leaders, negotiate priorities, and drive cross functional alignment.
• Excellent communication skills, with the ability to simplify complex concepts and provide clear direction.
• Demonstrated ability to lead teams through change, ambiguity, and evolving regulatory landscapes.

Required/Preferred Education and Licenses

• Bachelor's degree (or equivalent experience) required; advanced degree preferred.
• Progressive pharmaceutical industry experience, including global labeling or regulatory affairs.
• Demonstrated leadership experience managing teams and leading cross functional initiatives.