For Current Gilead Employees and Contractors:

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

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.

Job Description

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Sr. Manager, Labeling Operations

RESPONSIBILITIES:

• Contributes to the completion of all technical and operational activities for Labeling Operations projects through management of internal and external resources.
• Manages complex processes across functions and interacts effectively with team members to ensure product labeling meets regulatory requirements.
• Responsible for initiating and directing the implementation of labeling changes and new labeling introductions across multiple production sites.
• 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, 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.
• Ensures that labeling copy and graphics are in accordance with regulatory, market, industry, and corporate style guidelines.
• Directs activities within the Labeling Operations group to meet company goals including production schedules, budgeting, and performance reviews.
• Manages and develops a team of four Labeling Project Coordinators.
• Drives continuous improvement in Labeling Operations processes.
• Manages external vendor relationships and may participate in vendor audits with Quality Assurance.
• Supports internal and external audits as a labeling SME.
• Owns quality records such as CAPAs, Deviations, and Change Management related to labeling.
• Trains new employees on SOPs, guidelines, and QRGs.
• Authors SOPs and other supporting documents in a GMP system.
• Generates and maintains Learning Plans and Training Modules.

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.
• Strong 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:

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

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 careers@gilead.com for assistance.

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*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 careers@gilead.com 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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