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.
Requirements
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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Pay Range:
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Additional Information
Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.
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.
Cytokinetics · Ireland