Senior Manager, Labeling & Graphics Operations

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Owns quality records such as CAPAs, Deviations, and Change Management related to labeling.
• Manages external vendor relationships and may participate in vendor audits with Quality Assurance.
• Drives continuous improvement in Labeling Operations processes.
• Generates and maintains Learning Plans and Training Modules.
• Ensures that labeling copy and graphics are in accordance with regulatory, market, industry, and corporate style guidelines.
• Trains new employees on SOPs, guidelines, and QRGs.
• Reviews and approves Labeling Requests, Artwork Change Orders, and Proofs in Gilead’s PLM system.
• Directs the timing of labeling implementation and while coordinating the approvals between Regulatory, Quality Assurance, Marketing, Legal, Manufacturing and Package Engineering.
• Evaluates the flow of projects through the artwork development process against established timelines and prioritizes activities based on changing requirements.
• Authors SOPs and other supporting documents in a GMP system.
• Manages and develops a team of four Labeling Project Coordinators.
• Supports internal and external audits as a labeling SME.
• Manages complex processes across functions and interacts effectively with team members to ensure product labeling meets regulatory requirements.
• Contributes to the completion of all technical and operational activities for Labeling Operations projects through management of internal and external resources.
• Directs activities within the Labeling Operations group to meet company goals including production schedules, budgeting, and performance reviews.
• Responsible for initiating and directing the implementation of labeling changes and new labeling introductions across multiple production sites.

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

• Prior experience in pharmaceutical industry in Regulatory, Quality or Labeling Operations is required.
• 8+ years of relevant experience and a Bachelor Degree OR 6+ years of relevant experience and a MS.

The salary range for this position is: $149,600.00 - $193,600.00. Gilead 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*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.