Essential FunctionsLeadership, Visibility & Quality OwnershipLead 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 QualityOversee 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 InfluenceServe 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 ManagementLead 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 & EfficiencyIdentify, 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 & CultureBuild 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 AbilitiesDemonstrated 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 LicensesBachelor’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.
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