Manager, Labeling Operations
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. Gileads 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 companys five core values. Thats 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 #CreatingPossible
Manager, Labeling Operations
Specific Job 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 the other team members to ensure product labeling meets regulatory requirements.
- Generates and maintains Learning Plans and Training Modules.
- Trains new employees in SOPs and documentation systems.
- Responsible for initiating and directing the implementation of labeling changes and new labeling introductions on multiple projects across multiple production sites.
- Evaluates the tracking flow of projects through the artwork development process against established timelines and prioritizes activities based on changing requirements.
- Directs the timing and problem resolution while coordinating the approvals between Regulatory, Quality Assurance, Marketing, Legal, Manufacturing and Package Engineering.
- Manages labeling text, layout and format consistency within product family and product specific graphics.
- Ensures that packaging label copy and graphics are in accordance with regulatory, market , industry, and corporate style guidelines.
- Ensures all packaging documentation (Specifications, Master Production Records, Worksheets, etc.) are completed in a timely and accurate manner.
- Ensures the correct and consistent transfer and implementation of text, graphs, charts, tables, etc. in a clear and accurate manner, Errors, inconsistencies, conflicts, etc., require identification and resolution coordinated with appropriate functions.Directs activities within the labeling operations group to meet company goals including production schedules, budgeting, training, and performance reviews.
- Drives continuous improvement in all labeling operation processes.
- Manages any external vendor relationships and may participate in vendor audits with Quality Assurance.
- Directs activities within the Labeling Operations group to meet company goals including packaging, labeling, production schedules, budgeting, training and performance reviews.
- May or may not directly supervise others.
Knowledge & Skills
- 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, fonts, network issues, inspection systems).
Required Education & Experience:
- A Bachelor's Degree and a minimum of seven (7) years of relevant experience OR A Master's Degree and a minimum of five (5) years of relevant experience.
- Experience in the pharmaceutical industry in Regulatory, Quality or Labeling Operations.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' 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:
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