Manager, Labeling Operations

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Job Description

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.

The salary range for this position is : $133,280.00 - $172,480.00. 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*.