Associate Director, Product Artwork Management
BioMarin Pharmaceutical Inc.
August 31, 2026
Remote friendly (United States)
United States
$151,200 - $207,900 USD yearly
Marketing
Role Overview
- Lead end-to-end product artwork capability across the product lifecycle (development through commercialisation and lifecycle management), setting strategy and governance for accurate, compliant, on-time delivery of printed packaging components (labels, cartons, leaflets) across all markets.
Key Accountabilities
Artwork Strategy & Operating Model
- Define and implement a global printed-labelling (artwork) strategy and process across the portfolio and markets.
- Build standardized, fit-for-purpose processes/standards and ways of working across products, regions, and partners.
- Establish decision rights, prioritisation frameworks, and escalation pathways for artwork demand and change.
- Develop a multi-year roadmap for artwork capability, systems, and digital enablement (including AI-driven transformation).
Governance, Compliance & Inspection Readiness
- Own the artwork governance framework; ensure accurate, compliant, inspection-ready artwork.
- Maintain GxP-compliant SOPs, controls, and audit trails aligned to GMP, ICH, FDA, EMA.
- Ensure GMP change-control compliance and inspection readiness for labelling/artwork.
- Oversee Quality Event and CAPA management; deliver global labelling compliance KPIs and risk insights.
- Own Product Ownership & Coverage Model (tiering, role definition, backup coverage).
Artwork Lifecycle, Systems & Data
- Own end-to-end artwork lifecycle (concept through print/implementation) with right-first-time quality.
- Lead change-control execution and lifecycle optimisation (including phase-in/phase-out).
- Own and optimise core artwork/labelling systems and digital roadmap (e.g., GLAMS); direct selection, validation, and integration.
- Ensure data integrity, traceability, audit readiness; lead automation/analytics initiatives.
Launch & Lifecycle Readiness
- Lead artwork planning/readiness for new product introductions and global launches aligned to regulatory and supply milestones.
- Build rapid-response processes for safety/time-critical labelling updates while maintaining compliance.
- Lead cross-functional teams for timely roll-outs with Regulatory, Pharmacovigilance, and Manufacturing.
Cross-Functional Leadership & Vendor Management
- Act as artwork/labelling SME and integrator across matrix stakeholders.
- Partner with Manufacturing to ensure production-ready artwork.
- Provide governance oversight of external artwork vendors (performance, escalation, cost/lead-time/quality improvements).
People Leadership & Capability Building
- Line-manage Product Artwork Owners and Product Artwork Coordinators; build capability and a culture of continuous improvement.
- Define KPIs (cycle time, approval timelines, right-first-time, on-time delivery) and manage budget/vendor strategy.
Qualifications & Experience
- Bachelor’s degree in Life Sciences, Engineering, Supply Chain, or related field; MBA/MSc preferred.
- ~10–12+ years in pharmaceutical/biotech operations focused on artwork/labelling, product launch, or supply chain in GxP-regulated environments.
- Proven global cross-functional programme leadership and operating-model transformation.
- Strong matrix leadership experience.
- Strong knowledge of GMP, ICH, FDA, EMA; product lifecycle and labelling processes; packaging operations and systems (e.g., GLAMS, Veeva Vault).
Core Competencies
- Pharmaceutical regulatory & compliance; strategic operating-model design; lifecycle management.
- Cross-functional leadership, stakeholder influence, programme/project management.
- Risk-based decision making; process excellence and continuous improvement; executive communication.
- People leadership and capability building.
- Lead end-to-end product artwork capability across the product lifecycle (development through commercialisation and lifecycle management), setting strategy and governance for accurate, compliant, on-time delivery of printed packaging components (labels, cartons, leaflets) across all markets.
Key Accountabilities
Artwork Strategy & Operating Model
- Define and implement a global printed-labelling (artwork) strategy and process across the portfolio and markets.
- Build standardized, fit-for-purpose processes/standards and ways of working across products, regions, and partners.
- Establish decision rights, prioritisation frameworks, and escalation pathways for artwork demand and change.
- Develop a multi-year roadmap for artwork capability, systems, and digital enablement (including AI-driven transformation).
Governance, Compliance & Inspection Readiness
- Own the artwork governance framework; ensure accurate, compliant, inspection-ready artwork.
- Maintain GxP-compliant SOPs, controls, and audit trails aligned to GMP, ICH, FDA, EMA.
- Ensure GMP change-control compliance and inspection readiness for labelling/artwork.
- Oversee Quality Event and CAPA management; deliver global labelling compliance KPIs and risk insights.
- Own Product Ownership & Coverage Model (tiering, role definition, backup coverage).
Artwork Lifecycle, Systems & Data
- Own end-to-end artwork lifecycle (concept through print/implementation) with right-first-time quality.
- Lead change-control execution and lifecycle optimisation (including phase-in/phase-out).
- Own and optimise core artwork/labelling systems and digital roadmap (e.g., GLAMS); direct selection, validation, and integration.
- Ensure data integrity, traceability, audit readiness; lead automation/analytics initiatives.
Launch & Lifecycle Readiness
- Lead artwork planning/readiness for new product introductions and global launches aligned to regulatory and supply milestones.
- Build rapid-response processes for safety/time-critical labelling updates while maintaining compliance.
- Lead cross-functional teams for timely roll-outs with Regulatory, Pharmacovigilance, and Manufacturing.
Cross-Functional Leadership & Vendor Management
- Act as artwork/labelling SME and integrator across matrix stakeholders.
- Partner with Manufacturing to ensure production-ready artwork.
- Provide governance oversight of external artwork vendors (performance, escalation, cost/lead-time/quality improvements).
People Leadership & Capability Building
- Line-manage Product Artwork Owners and Product Artwork Coordinators; build capability and a culture of continuous improvement.
- Define KPIs (cycle time, approval timelines, right-first-time, on-time delivery) and manage budget/vendor strategy.
Qualifications & Experience
- Bachelor’s degree in Life Sciences, Engineering, Supply Chain, or related field; MBA/MSc preferred.
- ~10–12+ years in pharmaceutical/biotech operations focused on artwork/labelling, product launch, or supply chain in GxP-regulated environments.
- Proven global cross-functional programme leadership and operating-model transformation.
- Strong matrix leadership experience.
- Strong knowledge of GMP, ICH, FDA, EMA; product lifecycle and labelling processes; packaging operations and systems (e.g., GLAMS, Veeva Vault).
Core Competencies
- Pharmaceutical regulatory & compliance; strategic operating-model design; lifecycle management.
- Cross-functional leadership, stakeholder influence, programme/project management.
- Risk-based decision making; process excellence and continuous improvement; executive communication.
- People leadership and capability building.