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Manager, Labeling Operations

Gilead Sciences

Santa Monica, CAHybridPosted 40 days ago$123,930.00 - $160,380.00
Full TimeSenior LevelRegulatory AffairsPharmaceutical
Original posting ↗

Summary

Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.

Job description

Key Responsibilities

  • Manage commercial pharmaceutical labeling projects from initiation through implementation.
  • Coordinate labeling activities across Regulatory Affairs, Quality Assurance, Supply Chain, Manufacturing, Packaging Engineering, and external vendors.
  • Lead artwork development, review, approval, and implementation activities.
  • Manage project timelines, risks, priorities, and deliverables to ensure on-time execution.
  • Review and approve artwork proofs, printer proofs, and packaging components for accuracy and compliance.
  • Maintain labeling documentation, specifications, change controls, and related controlled records.
  • Identify and resolve labeling, artwork, and implementation issues.
  • Support labeling systems, workflows, and continuous improvement initiatives.

Basic Qualifications

  • BS/BA with 6+ years of relevant experience, or MS with 4+ years of relevant experience.
  • Direct experience managing commercial pharmaceutical labeling projects.
  • Experience with artwork development, artwork approval workflows, and labeling implementation.
  • Experience reviewing printer proofs and packaging artwork.
  • Strong understanding of commercial printing, packaging, and artwork production processes.
  • Knowledge of GMP requirements and pharmaceutical labeling regulations.
  • Experience working with cross-functional teams and external suppliers.
  • Strong project management, organizational, and communication skills.
  • Experience with document management, change control, and labeling systems.

Preferred Qualifications

  • Experience supporting biologics, cell therapy, or specialty pharmaceutical products.
  • Experience with Veeva Vault, GPLM, SmartSheet, or similar systems.
  • PMP certification or formal project management training.
  • Background in graphic arts, print production, packaging, or artwork management.
  • Experience supporting global labeling operations.

Requirements

  • BS/BA with 6+ years of relevant experience, or MS with 4+ years of relevant experience.
  • Direct experience managing commercial pharmaceutical labeling projects.
  • Experience with artwork development, artwork approval workflows, and labeling implementation.
  • Experience reviewing printer proofs and packaging artwork.
  • Strong understanding of commercial printing, packaging, and artwork production processes.
  • Knowledge of GMP requirements and pharmaceutical labeling regulations.
  • Experience working with cross-functional teams and external suppliers.
  • Strong project management, organizational, and communication skills.
  • Experience with document management, change control, and labeling systems.

Benefits

  • Medical, Dental & Vision
  • Life Insurance
  • Paid Time Off
  • Discretionary Annual Bonus
  • Stock-Based Long-Term Incentives

Company overview

Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.

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