Director, Packaging and Artwork Management

Job purpose

We are seeking a Director of Packaging & Artwork Management to lead the strategy, systems, and execution of artwork lifecycle management. Reporting to the VP of External Manufacturing, this role will build inspection-ready, scalable, and fit-for-purpose artwork capabilities, with a strong emphasis on Global market requirements. This role is accountable for establishing end-to-end artwork management, including system selection and validation, intake and workflow design, lifecycle processes, and regulatory alignment. The leader will operate in a fast-paced, resource-constrained environment, balancing compliance, speed, and efficiency while supporting global commercialization.

Responsibilities

Artwork Strategy & Systems

• Define and implement a scalable global artwork strategy aligned to company growth.
• Lead selection, validation, and deployment of Artwork Management Systems (AMS), including:
• Ensure systems are GxP-compliant, right-sized, and integrated with Regulatory, Quality, and ERP platforms as appropriate.

Intake, Triage & Workflow Management

• Establish a centralized intake and prioritization model for artwork requests across products and markets.
• Implement governance and prioritization frameworks (launches, lifecycle changes, safety updates).
• Deploy tracking tools and dashboards to provide visibility into timelines, risks, and bottlenecks.
• Align artwork demand with regulatory submissions and manufacturing schedules.

Artwork Lifecycle Management

• Design and implement end-to-end processes (creation, review, approval, change control).
• Enable efficient cross-functional workflows that minimize cycle time while ensuring compliance.
• Establish version control, audit trails, and documentation to support inspection readiness.
• Oversee mock-ups and concept artwork for regulatory and internal use.

Safety & Time-Critical Labeling Updates

• Build lean, rapid-response processes for safety-driven labeling updates.
• Ensure accelerated execution while maintaining full compliance.
• Coordinate with Regulatory, Pharmacovigilance, and Manufacturing to support timely multi-country implementation.

Packaging & External Manufacturing Integration

• Partner with External Manufacturing and CMOs to ensure artwork is production-ready.
• Align artwork processes with packaging operations, supply timelines, and launch readiness.
• Provide oversight to artwork vendors and packaging partners to ensure quality and consistency.

Compliance, Quality & Continuous Improvement

• Establish and maintain GMP-compliant SOPs, policies, and workflows.
• Ensure all activities are inspection-ready and aligned with global expectations.
• Drive improvements in cycle time, right-first-time performance, and process simplicity.

Leadership & Performance Management

• Act as the artwork and labeling SME across Regulatory, Quality, Supply Chain, and Commercial.
• Define and track KPIs (cycle time, approval timelines, right-first-time, on-time delivery).
• Manage budget and vendors with a focus on cost-effective, scalable solutions.

Qualifications

Required Experience

• Bachelor’s degree preferred
• 10+ years in pharmaceutical packaging, labeling, and artwork management within a GxP environment
• Demonstrated experience building artwork intake, triage, and tracking processes in fast-paced environments
• Track record of success implementing end-to-end artwork lifecycle management
• Proven success in managing time-critical labeling and safety updates and selecting and deploying validated AMS platforms

Leadership Capabilities

• Proven ability to build scalable processes from the ground up
• Strong stakeholder management and decision-making skills
• Ability to simplify complexity and drive execution in resource-constrained settings
  
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