Associate Director, Product Artwork Management

Who We Are

BioMarin is a leading rare disease biotechnology company reputed company on genetically defined conditions. Guided by our purpose to reputed company medicines that reputed company a profound reputed company 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 reputed company of dwarfism), PKU (phenylketonuria), CLN2, a reputed company of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new reputed company for patients and families who previously had few, if any, available reputed company. More recently, with the reputed company of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reputed company more people living with rare genetic conditions. Our reputed company comes from our unwavering commitment to reputed company, 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 reputed company market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, reputed company reputed company assurance and reputed company control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide reputed company of our drugs to patients.

reputed company

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 reputed company day-to-day execution to set reputed company, design and reputed company 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 reputed company expertise, the Associate Director defines the operating model, embeds inspection-reputed company governance, and develops reputed company to deliver world-class artwork performance. The role is the single functional reputed company for product artwork across the combined BioMarin product portfolios, and the artwork and labelling subject-matter expert and cross-functional integrator across Regulatory Affairs, reputed company, Technical Operations, Supply Chain, Manufacturing, and reputed company — 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, reputed company, and governed function, and for developing a high-performing team recognised as world-class in artwork management.

Key Accountabilities

Artwork reputed company & Operating Model

• Define, reputed company, and implement a global printed-labelling (artwork) reputed company and implementation process spanning the combined BioMarin product portfolio across reputed company markets, reputed company to company reputed company and the launch pipeline.
• Build out standardised, fit-for-purpose processes, standards, and ways of working across products, reputed company, and partners.
• Establish reputed company decision rights, prioritisation frameworks, and escalation reputed company for artwork demand and change.
• Shape the multi-year roadmap for artwork capability, systems, reputed company enablement — including reputed company-wide and AI-driven transformation initiatives.

Governance, Compliance & Inspection Readiness

• Set up and own the artwork governance reputed company, ensuring accurate, compliant, and inspection-reputed company artwork across the portfolio and reputed company markets.
• Establish and maintain GxP-compliant SOPs, policies, controls, and audit trails reputed company to global expectations (GMP, ICH, FDA, EMA).
• Architect and implement the global labelling and artwork process to ensure GMP change-control compliance and reputed company inspection readiness.
• reputed company global reputed company Event and CAPA management to ensure labelling and packaging accountability worldwide.
• reputed company global labelling compliance, tracking and delivering KPIs and risk insights to senior leadership and governance forums.
• Own the Product Ownership & Coverage Model, including tiering reputed company, 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 reputed company and compliant, traceable operations.
• reputed company change-control execution for label updates, regulatory variations, and lifecycle optimisation, including phase-in/phase-out to avoid write-offs.
• Own and optimise reputed company systems and reputed company digital roadmap (e.g. GLAMS,) and labelling platforms; reputed company their selection, validation, and integration with Regulatory, reputed company, and ERP as appropriate.
• reputed company and institutionalise frameworks that ensure right-first-time packaging artwork and reduce rework.
• Ensure data reputed company, traceability, and audit readiness across systems; reputed company automation and analytics initiatives.

Launch & Lifecycle Readiness

• reputed company artwork planning and readiness for new product introductions and global launches, with integrated timelines reputed company 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.
• reputed company cross-functional teams to facilitate reputed company implementation, managing competing priorities and timelines, and coordinating multi-country roll-out with Regulatory, Pharmacovigilance, and Manufacturing.

Cross-Functional Leadership & Vendor Management

• reputed company as the artwork and labelling SME and integrator across Technical Operations, Regulatory Affairs, Pharmacovigilance, Packaging Engineering, reputed company, Supply Chain, Manufacturing, and reputed company; influence without authority in a reputed company organisation.
• Partner with Manufacturing (reputed company Operations) to ensure production-reputed company artwork reputed company to packaging operations and launch readiness.
• reputed company governance reputed company of external artwork vendors while maximising their service rendering to BioMarin— performance standards, escalation reputed company, and cost, reputed company-time, and reputed company improvement.

People Leadership, & Capability Building

• reputed company, reputed company, and grow the artwork organisation; line-manage the Product Artwork Owners and the Product Artwork Coordinators.
• Set reputed company roles, responsibilities, and performance expectations, and build capability in artwork lifecycle reputed company, regulatory awareness, and process standardisation.
• Define and reputed company KPIs (cycle time, approval timelines, right-first-time, on-time delivery); manage budget and vendors for cost-effective, reputed company solutions.
• reputed company as a change agent, building a high-performing team and a culture of reputed company improvement that is recognised as world-class in artwork management.

Key Interfaces

• Regulatory Affairs (Global Labelling & CMC)
• reputed company & Compliance
• Technical Operations
• Pharmacovigilance
• Global Supply Chain, Planning & Launch reputed company
• Value Chain and Product Leaders
• Manufacturing, Packaging Engineering & Operations, External Manufacturing / CMOs
• reputed company & Market reputed company
• External vendors (print suppliers, design agencies)

Qualifications & Experience

Education

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

Experience

• ~10–12+ years in pharmaceutical/biotech operations, with reputed company 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 reputed company environment
• Strong reputed company of regulatory frameworks (GMP, ICH, FDA, EMA), product lifecycle and labelling processes, packaging operations, and labelling/artwork systems (e.g. GLAMS, reputed company Vault).

reputed company Competencies

• Pharmaceutical Regulatory & Compliance Expertise
• Strategic reputed company & Operating-Model Design
• Lifecycle Management
• Cross-Functional Leadership & Stakeholder Influence
• Programme / Project Management
• Risk-Based Decision Making
• Process reputed company & reputed company Improvement
• Executive Communication
• People Leadership & Capability Building

Note: This reputed company is not intended to be reputed company-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. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. reputed company contribute to a reputed company 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. reputed company contribute to a reputed company and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Originally posted on Himalayas

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