Senior Manager, Global Labeling Operations

Merck•Billerica, MA

1d•Hybrid

About The Position

The Global Labeling Excellence Lead is responsible for advancing operational excellence, process optimization, and continuous improvement across global labeling activities within Regulatory Quality Safety (RQS). This role partners closely with process owners and cross-functional stakeholders to assess, implement, and monitor efficient, compliant, and scalable labeling processes that support business priorities and regulatory expectations. As the successful GLE Lead, you will apply established continuous improvement and change-management methodologies to improve ways of working, strengthen documentation and tracking practices, and provide practical recommendations that enhance global labeling quality, compliance, and operational effectiveness.

Requirements

Bachelor’s degree in a science or health-related discipline; advanced degree (PhD, MD, MS, or PharmD) strongly preferred.
Minimum of 5-years of pharmaceutical industry or related experience
Strong project management skills, including stakeholder management and ability to demonstrate collaborative stakeholder engagement and influencing skills across a globally, matrix, cross-cultured environment.
Operational excellence and continuous improvement mindset; experience contributing to cross-functional initiatives, process improvement efforts, or operational excellence projects.
Demonstrated ability to manage multiple priorities, meet deadlines, work independently, and maintain accurate, high-quality documentation.
Digital fluency and willingness to adopt innovative ways of working
Experience in product labeling, regulatory affairs, regulatory operations, quality, or a related pharmaceutical or biotechnology function, preferably in a headquarters or regional environment.
Sound judgment, problem-solving capability, and comfort operating in complex, regulated environments.
Ability to adopt digital tools, analytics, automation, or AI-enabled solutions to improve ways of working.

Nice To Haves

Knowledge of global labeling regulations, regulatory submission processes, and health authority expectations.
Experience supporting labeling governance, commitment tracking, market implementation, or compliance monitoring activities.
Familiarity with change management, continuous improvement, process mapping, metrics, or operational performance tracking.
Experience working in matrixed, global organizations and partnering with regulatory, safety, quality, medical, commercial, and regional stakeholders.

Responsibilities

Support the development, maintenance, and review of documentation related to global labeling processes, including policies, standard operating procedures, work instructions, and supporting documents.
Coordinate and track labeling document updates, internal milestones, and stakeholder inputs to support timely execution and alignment across global and regional teams.
Develop and maintain global labeling project plans, submission timelines, and health authority interaction tracking to ensure commitments and deliverables are visible, current, and effectively managed.
Establish and oversee a comprehensive global labeling commitment tracker to promote timely follow-through, accountability, and alignment with regulatory expectations and required timelines.
Monitor implementation of new and updated labeling in markets, manage exceptions and deviations, and track compliance metrics to support on-time submissions and implementation.
Partner with cross-functional RQS stakeholders on quality documentation, filing timelines, safety-related commitments, and related operational deliverables.
Identify and implement process improvements, digital solutions, and new technologies that simplify work, improve labeling quality, and increase operational efficiency.