Lead, Instructional Design & Labeling Operations

Biopharma Careers

Thousand Oaks (CA)

On-site

USD 149,000 - 201,000

Full time

14 days+
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Benefits offered by this job

Flexible work models
Stock-based incentives
Total Rewards plan

Job summary

Amgen, headquartered in Thousand Oaks, seeks a Senior Manager of Instructional Design and Labeling Operations to lead the design team, govern IFU/NAF lifecycle, and drive regulatory readiness across labeling programs.

You will partner with Human Factors, Regulatory Labeling, Packaging Engineering, and Quality to ensure compliant, high‑quality, user‑focused materials, while building a scalable operating model that supports business goals and patient safety.

Qualifications

  • Minimum of 2 years of directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
  • Experience with regulated labeling, artwork, packaging, Human Factors, or related design operations.
  • Knowledge of IFUs, instructional materials, labeling/artwork development, or Health Authority submission support.

Responsibilities

  • Lead and develop a team of Instructional Design Engineers.
  • Own SOPs and process improvement for IFU/NAF lifecycle.
  • Coordinate cross‑functional activities across Human Factors, Regulatory Labeling, Packaging Engineering and Quality.
  • Manage vendors and external workers to ensure timely, compliant deliverables.
  • Ensure documentation traceability and audit readiness for all labeling operations.

Skills

People leadership
Cross-functional collaboration
Process ownership
Regulatory labeling knowledge

Education

Doctorate degree
Master’s degree
Bachelor’s degree
Associate’s degree
High school diploma

Job description

Amgen, headquartered in Thousand Oaks, seeks a Senior Manager of Instructional Design and Labeling Operations to lead the design team, govern IFU/NAF lifecycle, and drive regulatory readiness across labeling programs.

You will partner with Human Factors, Regulatory Labeling, Packaging Engineering, and Quality to ensure compliant, high‑quality, user‑focused materials, while building a scalable operating model that supports business goals and patient safety.

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