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, Pharmacovigilance, and Manufacturing.
Cross-Functional Leadership & Vendor Management
- 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.
People Leadership, & Capability Building
- 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.
Key Interfaces
- Regulatory Affairs (Global Labelling & CMC)
- Quality & Compliance
- Technical Operations
- Pharmacovigilance
- Global Supply Chain, Planning & Launch Excellence
- Value Chain and Product Leaders
- Manufacturing, Packaging Engineering & Operations, External Manufacturing / CMOs
- Commercial & Market Access
- External vendors (print suppliers, design agencies)
Qualifications & Experience
Education
- Bachelor’s degree in Life Sciences, Engineering, Supply Chain, or related field; advanced degree (MBA, MSc) preferred.
Experience
- ~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).
Core Competencies
- 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
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
