Senior Manager, Global Labeling

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

The Senior Manager, Global Labeling will lead strategic planning and implementation of product labeling across global markets to ensure regulatory compliance and brand conformity. This role ensures our Global Label Management organization meets objectives by overseeing labeling and artwork strategies across product lifecycles.

The Senior Manager will develop and implement procedures and policies for labeling and packaging to maintain the integrity of the labeling process. They will collaborate with cross-functional teams including IT, manufacturing, engineering, regulatory, marketing and supply chain to achieve robust artwork creation, maintenance and implementation strategies. The Senior Manager's expertise as the Labeling Subject Matter Expert (SME) and key interface for internal and external stakeholders is vital in providing guidance and ensuring alignment across business functions.

Responsibilities:

• Act as a Business Process Leader and functional expert for labeling.
• Build and lead a high-performing global labeling team, fostering a culture of excellence, accountability, and innovation across Global locations.
• Champion strategic planning and execution of global label changes and artwork approaches throughout product lifecycles.
• Develop strong working relationships with the key stakeholders within Global Manufacturing, Engineering, Regulatory, Marketing, IT, and Supply Chain.
• Develop and implement procedures and policies for labeling and packaging that ensure the integrity of the labeling process for audit readiness is maintained while optimizing process workflows.
• Ensure label accuracy by incorporating all internal and external regulatory mandates, marketing requirements, and specifications, within appropriate systems. This includes labels, IFUs, inserts/patient materials, and associated artwork.
• Drive label change projects for launches, site transfers, and regional changes.
• Lead end-to-end labeling and artwork change management: intake, prioritization, scheduling, cross-functional reviews, proofing/verification, translations, release, and implementation planning (effective dates, cut-in/cut-over, inventory depletion).
• Develop and report on performance metrics for labeling, design, execution and workflows. Develop and meet departmental budget.
• Support investigations for labeling-related nonconformances, deviations, and complaints; lead root cause analysis and drive effective CAPA and preventive actions.

Qualifications:

• Bachelor's degree required, preferred in Science, Engineering, Business or Supply Chain.
• Minimum of 3 years' supervisory or management experience with direct reports
• Minimum of 3 years combined experience in label creation, design, maintenance and approval workflows.
• Minimum of 8 years' production experience in a regulated industry; medical device experience strongly preferred (global labeling a plus).
• Ability to serve as subject matter expert in label design, execution, and workflows.
• Demonstrates strong project management skills, including stakeholder management with strong problem-solving, decision-making, and analytical skills.
• Experienced in upskilling teams, promoting digital transformation, and embedding agile practices.
• Authentically builds trusted relationships and collaborates across global, diverse, and multi-functional teams to drive business objectives.
• Understands regulatory implications of product strategy related to labeling development, assessment, and management in Medical Device and Biologic industries.
• Ability to travel domestically/internationally as needed to support manufacturing site operations.