Manager - Labelling

Amgen Inc.

3.6

(9)

Hyderabad, India

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-206581

    Position summary

    beling templates, SOPs, and related documentation to sustain consistency and compliance.

    Cross-Functional Collaboration

    • Collaborate with local, regional, and global teams-including Regulatory Affairs, Quality, and Supply Chain-to identify labeling requirements, address challenges, and meet project milestones.

    • Communicate clearly and proactively with relevant stakeholders, providing expertise on labeling processes and compliance requirements.

    Planning & Execution

    • Develop detailed project plans and timelines for labeling initiatives, ensuring completion within defined schedules.

    • Monitor progress, identify potential risks, and implement corrective actions to keep projects on track.

    Process Improvement & Compliance

    • Identify opportunities to streamline labeling workflows and enhance efficiency, driving continuous improvement within the labeling function.

    • Support inspection readiness by maintaining up-to-date records, robust quality checks, and accurate documentation for audit purposes.

    Technical & Operational Support

    • Perform critical reviews of artwork, translations, and labeling content to verify accuracy and adherence to regulatory standards.

    • Troubleshoot issues related to labeling systems, ensuring timely resolution and minimal operational disruption.

    Mentoring & Knowledge Sharing

    • Provide guidance and training to junior team members and new hires on labeling standards, tools, and best practices.

    • Foster a culture of knowledge-sharing and continuous learning to build expertise within the team.

    Qualifications

    Basic Qualifications:

    • Doctorate degree OR

    • Master's degree and 4 to 6 years of directly related experience OR

    • Bachelor's degree and 6 to 8 years of directly related experience OR

    • Diploma and 10 to 12 years of directly related experience

    Required Qualifications

    • Knowledge of Labeling Management Systems (e.g., Veeva Vault) and related document management tools.

    • Strong knowledge of global regulatory labeling requirements, especially for pharmaceuticals or biologics.

    • Proven track record in project planning and execution, with strong organizational and problem-solving skills.

    • Excellent communication skills, with the ability to collaborate effectively in a global, cross-functional environment.

    • Experience in continuous improvement methods to enhance labeling processes and efficiency.

    Soft Skills:

    • Excellent written/oral communication skills and attention to detail

    • Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;

    • Proficient time and project management skills.

    • Self-starter with a drive and perseverance to achieve results

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging