Job Location : Convent Station,NJ, USA
* Define and own the global artwork lifecycle strategy across the product lifecyclefrom design initiation to commercial execution.* Lead the transformation roadmap, including simplification, harmonization, and integration of global artwork processes.* Establish and maintain global governance frameworks, including SOPs, KPIs, change controls, and audit readiness protocols.* Chair and lead the Global Artwork Community of Practice to ensure knowledge sharing, standard adoption, and continuous capability building.* Align artwork process strategies with broader M&S, Regulatory, Quality, and Digital objectives.* Lead change management initiatives related to artwork process updates, system enhancements, and global harmonizationensuring smooth adoption and minimal disruption across sites and functions.* Design and deliver training programs in collaboration with regional and local artwork teams to build capabilities on new tools, standards, and ways of working.* Establish and maintain a central knowledge repository for artwork managementincluding SOPs, playbooks, best practices, and lessons learnedto ensure global consistency and transparency.* Act as a mentor and subject matter expert for artwork leads and execution teams, providing ongoing guidance, coaching, and process support.* Collaborate with Quality, Regulatory, and Risk functions to identify key process risks, and drive optimization, simplification, or standardization efforts where needed.* Act as the business owner for global artwork systems such as OnePack, VISTAlink, and other AMS platforms.* Collaborate with Digital to ensure system scalability, data governance, and compliance with validation and cybersecurity standards.* Ensure global compliance with regulatory frameworks, including HA requirements, CCDS alignment, and GMP standards.* Oversee global artwork change control processes and validation protocols.* Monitor regulatory trends and implement timely updates in coordination with Regulatory Affairs and local markets.* Track and resolve non-compliance issues and maintain robust documentation for audits.* Collaborate with senior leaders and stakeholders across Regulatory Affairs, Quality Assurance, Manufacturing & Supply, Commercial, and Digital to ensure artwork processes are fully aligned with business strategy, operational priorities, and product lifecycle milestones.* Serve as the primary liaison between global and regional Artwork functions, system owners (e.g., Digital/IT), and enterprise support functions (e.g., Finance, Procurement) to facilitate process alignment, knowledge sharing, and effective integration of new tools and methodologies.* Provide functional direction to site-level artwork teams, including capability building, training programs, and performance coaching.* Act as the central liaison across global and local teams to harmonize execution and reduce variability.* BS/BA degree-ideally in a Scientific discipline, Regulatory, Manufacturing, Supply Chain or related but will consider all degrees. Masters degree is preferred, but not required.* Minimum of 8 years of experience ideally within the pharmaceutical or biotechnology industry, with direct exposure to Artwork, Labeling, Regulatory Affairs, or Manufacturing & Supply.* Strong understanding of regulatory compliance requirements (e.g., GMP, CCDS, HA submissions) and global artwork-related standards and best practices.* Proven experience in leading digital transformation initiatives, particularly involving artwork process and systems implementation, lifecycle automation, or process digitization within a regulated industry.* Demonstrated leadership and team management capabilities, with experience steering cross-functional and multicultural teams.* Outstanding communication and stakeholder engagement skills, with the ability to align diverse global functions around strategic goals.* Agile mindset with a strong problem-solving orientation and a history of successful project delivery in complex environments.* Regulatory certifications (e.g., RAC) or equivalent professional credentials are a plus.* Masters degree is preferred.* Experience in Artwork, packaging and/or design to Value (DTV) is a plus* **Languages**: French is a plus* **Willing to challenge conventional thinking*** Not reluctant to make tough/unpopular decisions and to face conflict. Motivated and able to motivate others around him/her* **Strong communication and inter-personal skills**, especially in a cross-functional context. Ability to maneuver in cross-functional setups and to generate buy-in across different stakeholders is a plus* **Robust project management skills** (incl. planning) Able to develop comprehensive workable solutions incorporating the constraints and inputs from all functions in complex situations* **Ability to quickly draw the big picture and solve problems:** understand quickly the key issues at stake for the different functions and develop workable solutions accordingly.**Technical skills**:* Bring the miracles of science to life alongside a supportive, future-focused team.* Discover endless opportunities to gain experience and drive your career, whether its through a promotion or lateral move, at home or internationally.* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.* Take diligent care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
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