Associate Director, Product Artwork Management

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.

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

Bachelor’s degree in Life Sciences, Engineering, Supply Chain, or related field; advanced degree (MBA, MSc) preferred.

~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

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.

The salary range for this position is: $151,200 to $207,900. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.