Director, Packaging and Artwork Management

Cytokinetics is a late-stage specialty cardiovascular biopharmaceutical company focused on discovering developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

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

• Bachelors 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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Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

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Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer