Senior Manager, Instructional Design and Labeling Operations

Regulatory Toolkit; Thousand Oaks (CA); Presencial; USD 149.000 - 201.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement plan

Medical/dental/vision coverage

Life & disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Paid time off

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

People leadership

Stakeholder management

Regulated labeling

Process ownership

Cross-functional collaboration

Educación

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma

Descripción del empleo

Senior Manager, Instructional Design and Labeling Operations

Career Category: Engineering | Location: Thousand Oaks, California, US

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas - Oncology, Inflammation, General Medicine, and Rare Disease - we reach millions of patients each year.

What you will do

The Senior Manager, Instructional Design and Labeling Operations will lead the Instructional Design team within Customer Experience and Design, supporting the development, lifecycle management, review, and operational execution of Instructions for Use (IFUs), Native Artwork Files (NAFs), and related instructional artwork deliverables for combination products and other regulated medical products.

This role is first and foremost a people leadership and operational excellence role. The Senior Manager will lead a mixed team of Amgen employees and external workers, build team capability, strengthen career development, manage capacity and priorities, and mature the Instructional Design and Labeling Operations function. The role will also own the process governance, implementation, adherence, and continuous improvement of SOP-437076, ensuring Instructional Design workflows are clear, scalable, compliant, and effectively integrated into cross-functional product development and submission activities.

The successful candidate does not need to be a formal instructional designer, but must bring strong people leadership, process ownership, stakeholder management, and regulated medical product experience. This leader will partner closely with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Final Product Teams, Quality, vendors, and other cross-functional stakeholders.

Key Responsibilities

People Leadership and Team Development

• Lead, coach, and develop a team of Instructional Design Engineers.
• Serve as a career development champion by clarifying role expectations, supporting development plans, and creating growth opportunities.
• Build a high-performing team culture grounded in accountability, collaboration, learning, quality, operational discipline, and customer focus.
• Manage team priorities, workload, capacity, onboarding, performance, development, and resource allocation.
• Provide effective oversight of external workers and/or contractors.
• Help the team navigate ambiguity, competing priorities, cross-functional dependencies, and escalation needs.

Functional Leadership and Operating Model

• Lead the Instructional Design and Labeling Operations function within Customer Experience and Design.
• Translate portfolio needs, Human Factors milestones, labeling deliverables, study timelines, submission needs, and business priorities into executable team plans.
• Establish mechanisms to monitor workload, workflow health, quality trends, cycle times, risks, rework drivers, and delivery commitments.
• Strengthen the operating model, including role clarity, decision rights, intake, prioritization, escalation, metrics, and cross-functional handoffs.
• Ensure the team's work supports broader Customer Experience objectives, including improved patient learning materials, usability, and complaint reduction.

SOP Ownership and Process Improvement

• Lead process improvement across the IFU / NAF lifecycle, including NAF strategy, creation, revision, review cycles, Human Factors study support, source text alignment, submission support, vendor coordination, and launch readiness.
• Develop, maintain, and improve templates, checklists, standards, process maps, training materials, metrics, and review expectations.
• Identify and resolve process gaps, handoff inefficiencies, documentation risks, and compliance vulnerabilities.
• Champion scalable and compliant ways of working that improve predictability, audit readiness, quality, and speed of execution.

Instructional Design, Labeling Operations, and Regulated Artwork Oversight

• Provide leadership oversight for development and revision of IFUs, instructional artwork, illustrations, NAFs, study stimuli, and related deliverables supporting development, Human Factors studies, Health Authority interactions, and commercialization.
• Ensure deliverables address user needs, usability principles, labeling requirements, regulatory expectations, documentation traceability, and quality standards.
• Oversee NAF strategy, artwork creation, review cycles, source text alignment, print readiness, study stimuli preparation, vendor coordination, and submission readiness.
• Ensure appropriate quality checks, review discipline, documentation, and inspection practices are in place.
• Support issue resolution when design, usability, labeling, regulatory, packaging, artwork, quality, or operational considerations conflict.

Cross-Functional Collaboration and Vendor Management

• Build strong partnerships with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Quality, Final Product Teams, and vendors.
• Represent the function in portfolio, program, governance, and process discussions.
• Communicate priorities, risks, decisions, and tradeoffs clearly to senior leaders and stakeholders.
• Manage vendor and contractor relationships to support execution, capacity, quality, print readiness, and study support.

Quality, Compliance and Inspection Readiness

• Ensure activities are performed and documented in accordance with applicable procedures, standards, and regulatory expectations.
• Promote strong documentation practices, including traceability of inputs, decisions, reviews, revisions, and approvals.
• Support audit readiness, inspection readiness, and response to Health Authority questions related to Instructional Design and labeling deliverables.
• Drive a culture of quality ownership, right-first-time execution, and continuous learning.

What we expect of you

Basic Qualifications

Experience below refers to regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience:

• Doctorate degree and 2 years of experience; OR
• Master's degree and 6 years of experience; OR
• Bachelor's degree and 8 years of experience; OR
• Associate's degree and 10 years of experience; OR
• High school diploma / GED and 12 years of experience

And a minimum of 2 years' experience directly managing people and/or leading teams, projects, programs, or directing the allocation of resources (may run concurrently).

Preferred Qualifications

• Demonstrated people leadership, including coaching, performance management, career development, and building high-performing teams.
• Experience leading FTEs, external workers, contractors, vendors, or matrixed contributors in a regulated environment.
• Experience in regulated medical product labeling, artwork, packaging, Human Factors, medical device, pharmaceutical, biotechnology, combination product, quality, or design operations.
• Combination product experience preferred.
• Experience improving processes, implementing SOPs, developing templates/checklists, and scaling functional operations.
• Experience owning or governing controlled procedures, including training, inspection readiness, and continuous improvement.
• Knowledge of IFUs, labeling/artwork development, Human Factors study materials, Health Authority submission support, or regulated document workflows.
• Experience with document management systems, review workflows, source text/artwork alignment, traceability, and audit-ready documentation.
• Vendor management experience.
• Strong cross-functional leadership, influencing, written, verbal, and executive communication skills.
• Lean, Six Sigma, process excellence, change management, or operational excellence experience preferred.

What you can expect of us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $148,715.15 - $201,202.85 USD. Actual salary will vary based on relevant skills, experience, and qualifications.

In addition to base salary, Amgen offers a Total Rewards Plan, based on eligibility, that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Application deadline: Amgen does not have an application deadline for this position; applications will be accepted until a sufficient number is received or a candidate is selected.

Sponsorship: Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. Reasonable accommodations are available for individuals with disabilities upon request.