Manager, Labeling Operations

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Job description

Manager, Labeling Operations
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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 .

For additional benefits information, visit:

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

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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