Manager Labeling

Labeling Manager

Relocation: This is an on-site role and will provide relocation assistance. The company is located in the Upper Mid-West.

Position Overview:

We are seeking a detail-oriented Labeling Manager to oversee all aspects of product labeling throughout the product lifecycle. This role will ensure that labeling content meets regulatory standards, is produced accurately, and is effectively managed across internal teams and external vendors. This role will expand and develop a new Labeling platform.

Key Responsibilities:

• Oversee Labeling Processes: Manage the development, approval, and implementation of labels and artwork for primary, secondary, and packaging components. Ensure all labeling is accurate, compliant, and reconciled appropriately.
• Ensure Regulatory Compliance: Maintain adherence to labeling regulations, including 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and other international guidelines throughout the product lifecycle.
• Optimize Labeling Procedures: Develop and maintain efficient labeling workflows that support accuracy, consistency, and compliance across product lines. Implement controls such as document management, change tracking, and review cycles to uphold labeling integrity.
• Cross-Functional Collaboration: Work closely with Regulatory Affairs, Quality Assurance, and Manufacturing teams to align labeling requirements, address updates, and manage any challenges. Support teams with artwork development, proofreading, and version control.
• Stay Ahead of Industry Trends: Keep up to date with evolving regulations, technological advancements, and best practices in labeling. Identify and implement process improvements to enhance efficiency and automation in labeling operations.

Qualifications & Requirements:

• Minimum of 5 years of experience in drug product labeling and artwork management.
• Familiarity with labeling equipment qualification and labeling process validation is a plus.
• Bachelor’s degree required (Life Sciences or related field preferred).
• Strong background in cGMP and GDP compliance with a proven ability to maintain regulatory adherence.
• In-depth knowledge of FDA and EU labeling regulations, including 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and relevant global standards.

This role offers the opportunity to make a meaningful impact by ensuring high-quality, compliant labeling that supports the success of our products worldwide.