Associate Director, Product Artwork Management

BioMarin Pharmaceutical Inc. is a leading rare disease biotechnology company focused on genetically defined conditions. The Associate Director, Product Artwork Management leads the end-to-end product artwork capability across the product lifecycle, ensuring accurate and compliant delivery of printed packaging components while establishing governance and scaling processes.

Responsibilities:

• Define, scale, and implement a global printed-labelling (artwork) strategy and implementation process spanning the combined BioMarin product portfolio across all markets, aligned to company growth and the launch pipeline
• Build out standardised, fit-for-purpose processes, standards, and ways of working across products, regions, and partners
• Establish clear decision rights, prioritisation frameworks, and escalation pathways for artwork demand and change
• Shape the multi-year roadmap for artwork capability, systems, and digital enablement — including enterprise-wide and AI-driven transformation initiatives
• Set up and own the artwork governance framework, ensuring accurate, compliant, and inspection-ready artwork across the portfolio and all markets
• Establish and maintain GxP-compliant SOPs, policies, controls, and audit trails aligned to global expectations (GMP, ICH, FDA, EMA)
• Architect and implement the global labelling and artwork process to ensure GMP change-control compliance and continuous inspection readiness
• Oversee global Quality Event and CAPA management to ensure labelling and packaging accountability worldwide
• Lead global labelling compliance, tracking and delivering KPIs and risk insights to senior leadership and governance forums
• Own the Product Ownership & Coverage Model, including tiering criteria, role definition, and backup coverage
• Own the end-to-end artwork lifecycle — concept, design, development, review, approval, print, and implementation — ensuring right-first-time quality and compliant, traceable operations
• Lead change-control execution for label updates, regulatory variations, and lifecycle optimisation, including phase-in/phase-out to avoid write-offs
• Own and optimise core systems and related digital roadmap (e.g. GLAMS,) and labelling platforms; direct their selection, validation, and integration with Regulatory, Quality, and ERP as appropriate
• Develop and institutionalise frameworks that ensure right-first-time packaging artwork and reduce rework
• Ensure data integrity, traceability, and audit readiness across systems; lead automation and analytics initiatives
• Lead artwork planning and readiness for new product introductions and global launches, with integrated timelines aligned to regulatory and supply milestones
• Identify operational gaps and implement strategic process improvements to mitigate risk globally
• Build lean, rapid-response processes for safety-driven and time-critical labelling updates, maintaining full compliance
• Lead cross-functional teams to facilitate timely implementation, managing competing priorities and timelines, and coordinating multi-country roll-out with Regulatory, Pharmacovigilance, and Manufacturing
• Act as the artwork and labelling SME and integrator across Technical Operations, Regulatory Affairs, Pharmacovigilance, Packaging Engineering, Quality, Supply Chain, Manufacturing, and Commercial; influence without authority in a matrix organisation
• Partner with Manufacturing (Internal and External Operations) to ensure production-ready artwork aligned to packaging operations and launch readiness
• Provide governance oversight of external artwork vendors while maximising their service rendering to BioMarin— performance standards, escalation pathways, and cost, lead-time, and quality improvement
• Lead, develop, and grow the artwork organisation; line-manage the Product Artwork Owners and the Product Artwork Coordinators
• Set clear roles, responsibilities, and performance expectations, and build capability in artwork lifecycle excellence, regulatory awareness, and process standardisation
• Define and track KPIs (cycle time, approval timelines, right-first-time, on-time delivery); manage budget and vendors for cost-effective, scalable solutions
• Act as a change agent, building a high-performing team and a culture of continuous improvement that is recognised as world-class in artwork management

Requirements:

• Bachelor's degree in Life Sciences, Engineering, Supply Chain, or related field
• ~10–12+ years in pharmaceutical/biotech operations, with focus on artwork/labelling, product launch, or supply chain in GxP-regulated environments
• Proven experience leading global, cross-functional programmes and building or transforming an operating model
• Strong experience leading teams and executing work in a matrix environment
• Strong command of regulatory frameworks (GMP, ICH, FDA, EMA), product lifecycle and labelling processes, packaging operations, and labelling/artwork systems (e.g. GLAMS, Veeva Vault)
• Pharmaceutical Regulatory & Compliance Expertise
• Strategic Vision & Operating-Model Design
• Lifecycle Management
• Cross-Functional Leadership & Stakeholder Influence
• Programme / Project Management
• Risk-Based Decision Making
• Process Excellence & Continuous Improvement
• Executive Communication
• People Leadership & Capability Building
• advanced degree (MBA, MSc)