Manager, Labeling Operations

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RESPONSIBILITIES:

• Contributes to the completion of activities for Labeling Operations through management of internal and external resources.
• Manages complex processes across functions and interacts effectively with team members to ensure labeling meets technical requirements.
• Evaluates the flow of projects through the artwork development process against established timelines and prioritizes activities based on changing requirements.
• Reviews and approves Labeling Requests, Artwork Change Orders, Proofs, and Master Data in Gilead’s Labeling & Artwork Management (LAM) system.
• Provides support and recommendations for enhancements to Gilead’s LAM system.
• Serve as a project lead or lead representative from Labeling Operations.
• Ensures that labeling in development is in accordance with regulatory, market, industry, and corporate style guidelines.
• Targets the timing of labeling implementation while coordinating the approvals between Regulatory, Quality Assurance, Marketing, Legal, Manufacturing and Package Engineering.
• Directs activities within the Labeling Operations Group to meet company goals including production schedules, budgeting, and strategic objectives.
• Works on problems ranging from routine to moderately complex in scope where analysis of situations or data requires in-depth evaluation.
• Drives continuous improvement in Labeling Operations processes.
• Manages external vendor relationships and may participate in vendor audits with Quality Assurance.
• Owns quality records such as CAPAs, Deviations, and Change Management.
• Authors SOPs and other controlled documents in a GMP system.
• Generates and maintains Learning Plans and Training Modules.
• May or may not directly supervise others.

PREFERRED REQUIREMENTS:

• Strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents.
• Excellent verbal, written, and interpersonal communication skills.
• Outstanding computer, organizational, and project management skills.
• Able to direct and implement technical/electronic solutions for supporting Labeling Operations systems (i.e., software, network issues, inspection systems).

BASIC REQUIREMENTS:

• 6+ years of relevant experience and a bachelor’s degree.
• 4+ years of relevant experience and a MS.