Role Overview

Role Overview

The Associate Director, Product Artwork Management leads the end-to-end product artwork capability across the product lifecycle — from development through commercialisation and lifecycle management. The role moves the function beyond day-to-day execution to set strategy, design and scale fit-for-purpose processes, and establish the governance that ensures accurate, compliant, and on-time delivery of printed packaging components (labels, cartons, leaflets) for every market BioMarin serves.

The Associate Director, Product Artwork Management leads the end-to-end product artwork capability across the product lifecycle — from development through commercialisation and lifecycle management. The role moves the function beyond day-to-day execution to set strategy, design and scale fit-for-purpose processes, and establish the governance that ensures accurate, compliant, and on-time delivery of printed packaging components (labels, cartons, leaflets) for every market BioMarin serves.

Leveraging deep regulatory and quality expertise, the Associate Director defines the operating model, embeds inspection-ready governance, and develops the team to deliver world-class artwork performance. The role is the single functional lead for product artwork across the combined BioMarin product portfolios, and the artwork and labelling subject-matter expert and cross-functional integrator across Regulatory Affairs, Quality, Technical Operations, Supply Chain, Manufacturing, and Commercial — enabling successful launches and uninterrupted supply to patients.

Leveraging deep regulatory and quality expertise, the Associate Director defines the operating model, embeds inspection-ready governance, and develops the team to deliver world-class artwork performance. The role is the single functional lead for product artwork across the combined BioMarin product portfolios, and the artwork and labelling subject-matter expert and cross-functional integrator across Regulatory Affairs, Quality, Technical Operations, Supply Chain, Manufacturing, and Commercial — enabling successful launches and uninterrupted supply to patients.

This is a build-and-grow mandate: the Associate Director is accountable for maturing artwork management from individual product ownership into a standardised, scalable, and governed function, and for developing a high-performing team recognised as world-class in artwork management.

This is a build-and-grow mandate: the Associate Director is accountable for maturing artwork management from individual product ownership into a standardised, scalable, and governed function, and for developing a high-performing team recognised as world-class in artwork management.

Key Accountabilities

Key Accountabilities

Key Accountabilities

Artwork Strategy & Operating Model

Artwork Strategy & Operating Model

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.

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.

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.

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.

Shape the multi-year roadmap for artwork capability, systems, and digital enablement — including enterprise-wide and AI-driven transformation initiatives.

Governance, Compliance & Inspection Readiness

Governance, Compliance & Inspection Readiness

Set up and own the artwork governance framework, ensuring accurate, compliant, and inspection-ready artwork across the portfolio and all markets.

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).

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.

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.

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.

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 Product Ownership & Coverage Model, including tiering criteria, role definition, and backup coverage.

Artwork Lifecycle, Systems & Data

Artwork Lifecycle, Systems & Data

Own the end-to-end artwork lifecycle — concept, design, development, review, approval, print, and implementation — ensuring right-first-time quality and compliant, traceable operations.

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.

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.

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.

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.

Ensure data integrity, traceability, and audit readiness across systems; lead automation and analytics initiatives.

Launch & Lifecycle Readiness

Launch & Lifecycle Readiness

Lead artwork planning and readiness for new product introductions and global launches, with integrated timelines aligned to regulatory and supply milestones.

Lead artwork planning and readiness for new product introductions and global launches, with integrated timelines aligned to regulatory and supply milestones.