Senior Leader, Instructional Design & Labeling Operations

Regulatory Toolkit; Thousand Oaks (CA); On-site; USD 149,000 - 201,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Life & disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Paid time off

Job summary

Amgen is seeking a Senior Manager to lead the Instructional Design and Labeling Operations team within Customer Experience and Design. This role focuses on developing Instructions for Use, Native Artwork Files, and related instructional artwork for regulated medical products, while driving governance and continuous improvement.

The candidate should excel in people leadership, process ownership, and cross-functional collaboration with Human Factors, Regulatory Labeling, Packaging Engineering, and

Qualifications

• Experience in regulated labeling, medical devices, or combination products.
• Leadership experience with diverse teams, external workers, and vendors.
• Ability to manage SOPs, templates, and documentation in a regulated environment.

Responsibilities

• Lead Instructional Design and Labeling Operations team.
• Own process governance and SOP-437076 adherence.
• Partner with cross-functional stakeholders to meet regulatory timelines.
• Ensure quality checks and audit readiness across labeling deliverables.
• Manage vendor relationships and external workers as needed.

Skills

People leadership

Stakeholder management

Regulated labeling

Process ownership

Cross-functional collaboration

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Job description

Amgen is seeking a Senior Manager to lead the Instructional Design and Labeling Operations team within Customer Experience and Design. This role focuses on developing Instructions for Use, Native Artwork Files, and related instructional artwork for regulated medical products, while driving governance and continuous improvement.

The candidate should excel in people leadership, process ownership, and cross-functional collaboration with Human Factors, Regulatory Labeling, Packaging Engineering, and