Associate Director, Product Artwork Management

Description

• Who We Are

• BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

• Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

• Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

• About Technical Operations

• BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

• 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.

• 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.

• Key Accountabilities

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Launch & Lifecycle Readiness

• 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, Pharm