Associate Director, Product Artwork Management

b'nnnnnnnn Associate Director, Product Artwork Management | BioMarinnnnn n n nnntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnnn nn

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n BioMarin Pharmaceuticaln

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Associate Director, Product Artwork Management

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Location: United States

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Workstyle: Remote Only

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Apply

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Who We Are

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

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Guided by our purpose to develop medicines that make a profound impact on peoplexe2x80x99s 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.

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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.

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About Technical Operations

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BioMarinxe2x80x99s 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 BioMarinxe2x80x99s 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.

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Role Overview

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The Associate Director, Product Artwork Management leads the end-to-end product artwork capability across the product lifecycle xe2x80x94 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.

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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 xe2x80x94 enabling successful launches and uninterrupted supply to patients.

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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.

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Key Accountabilities

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Artwork Strategy & Operating Model

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• 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. n
• Build out standardised, fit-for-purpose processes, standards, and ways of working across products, regions, and partners. n
• Establish clear decision rights, prioritisation frameworks, and escalation pathways for artwork demand and change. n
• Shape the multi-year roadmap for artwork capability, systems, and digital enablement xe2x80x94 including enterprise-wide and AI-driven transformation initiatives. n

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Governance, Compliance & Inspection Readiness

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• Set up and own the artwork governance framework, ensuring accurate, compliant, and inspection-ready artwork across the portfolio and all markets. n
• Establish and maintain GxP-compliant SOPs, policies, controls, and audit trails aligned to global expectations (GMP, ICH, FDA, EMA). n
• Architect and implement the global labelling and artwork process to ensure GMP change-control compliance and continuous inspection readiness. n
• Oversee global Quality Event and CAPA management to ensure labelling and packaging accountability worldwide. n
• Lead global labelling compliance, tracking and delivering KPIs and risk insights to senior leadership and governance forums. n
• Own the Product Ownership & Coverage Model, including tiering criteria, role definition, and backup coverage. n

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Artwork Lifecycle, Systems & Data

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• Own the end-to-end artwork lifecycle xe2x80x94 concept, design, development, review, approval, print, and implementation xe2x80x94 ensuring right-first-time quality and compliant, traceable operations. n
• Lead change-control execution for label updates, regulatory variations, and lifecycle optimisation, including phase-in/phase-out to avoid write-offs. n
• 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. n
• Develop and institutionalise frameworks that ensure right-first-time packaging artwork and reduce rework. n
• Ensure data integrity, traceability, and audit readiness across systems; lead automation and analytics initiatives. n

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Launch & Lifecycle Readiness

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• Lead artwork planning and readiness for new product introductions and global launches, with integrated timelines aligned to regulatory and supply milestones. n
• Identify operational gaps and implement strategic process improvements to mitigate risk globally. n
• Build lean, rapid-response processes for safety-driven and time-critical labelling updates, maintaining full compliance. n
• Lead cross-functional teams to facilitate timely implementation, managing competing priorities and timelines, and coordinating multi-country roll-out with Regulatory, Pharmacovigilance, and Manufacturing. n

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Cross-Functional Leadership & Vendor Management

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• 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. n
• Partner with Manufacturing (Internal and External Operations) to ensure production-ready artwork aligned to packaging operations and launch readiness. n
• Provide governance oversight of external artwork vendors while maximising their service rendering to BioMarinxe2x80x94 performance standards, escalation pathways, and cost, lead-time, and quality improvement. n

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People Leadership, & Capability Building

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• Lead, develop, and grow the artwork organisation; line-manage the Product Artwork Owners and the Product Artwork Coordinators. n
• Set clear roles, responsibilities, and performance expectations, and build capability in artwork lifecycle excellence, regulatory awareness, and process standardisation. n
• Define and track KPIs (cycle time, approval timelines, right-first-time, on-time delivery); manage budget and vendors for cost-effective, scalable solutions. n
• 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. n

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Key Interfaces

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

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Qualifications & Experience

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Education

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• Bachelorxe2x80x99s degree in Life Sciences, Engineering, Supply Chain, or related field; advanced degree (MBA, MSc) preferred. n

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Experience

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• ~10xe2x80x9312+ years in pharmaceutical/biotech operations, with focus on artwork/labelling, product launch, or supply chain in GxP-regulated environments. n
• Proven experience leading global, cross-functional programmes and building or transforming an operating model. n
• Strong experience leading teams and executing work in a matrix environment n
• 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). n

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Core Competencies

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

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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.

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Equal Opportunity Employer/Veterans/Disabled

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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.

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Ireland Safety Responsibility Support the organisationxe2x80x99s 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 organisationxe2x80x99s 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.

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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.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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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.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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