Senior Manager, Instructional Design and Labeling Operations

Senior Manager, Instructional Design and Labeling Operations The Senior Manager will lead the Instructional Design team within Customer Experience and Design, managing a mixed workforce of Amgen employees and external workers. The role focuses on people leadership, operational excellence, and regulatory compliance for Instructions for Use (IFUs), Native Artwork Files (NAFs), and related instructional artwork deliverables for combination and other regulated medical products. Key Responsibilities People Leadership and Team Development Lead, coach, and develop Instructional Design Engineers; champion career development and growth opportunities. Build a high‑performing culture grounded in accountability, collaboration, learning, and quality. Manage priorities, workload, capacity, onboarding, performance, and resource allocation. Oversee external workers and contractors, ensuring integration and quality of deliverables. Navigate ambiguity, cross‑functional dependencies, and escalation needs. Functional Leadership and Operating Model Translate portfolio needs and regulatory milestones into executable team plans. Establish mechanisms for workload monitoring, workflow health, quality trends, cycle times, risks, and rework drivers. Strengthen the operating model with role clarity, decision rights, intake, prioritization, and cross‑functional handoffs. Ensure alignment with broader Customer Experience objectives, improving patient learning, usability, and customer experience outcomes. SOP Ownership and Process Improvement Lead continuous improvement across the IFU/NAF lifecycle, including strategy, creation, revision, review cycles, and launch readiness. Develop and update tools such as templates, checklists, standards, process maps, metrics, and training materials. Identify & resolve process gaps, handoff inefficiencies, documentation risks, and compliance vulnerabilities. Champion scalable, compliant ways of working that enhance predictability, audit readiness, and quality. Instructional Design, Labeling Operations, and Regulated Artwork Oversight Provide oversight for the development and revision of IFUs, instructional artwork, illustrations, NAFs, study stimuli, and related deliverables. Ensure compliance with user needs, usability principles, labeling requirements, regulatory expectations, and quality standards. Manage quality checks, review discipline, documentation, and inspection practices before formal review or submission. Resolve design, usability, labeling, regulatory, packaging, or quality conflicts. Cross‑Functional Collaboration and Vendor Management Build strong partnerships with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, and other functional teams. Represent the function in portfolio, program, governance, and process discussions to influence alignment and remove barriers. Manage vendor and contractor relationships, ensuring expectations, timelines, and quality standards are met. Quality, Compliance and Inspection Readiness Document and perform activities in accordance with applicable procedures and regulatory expectations. Promote strong documentation practices, traceability, audit readiness, and inspection readiness. Drive a culture of quality ownership, continuous learning, and right‑first‑time execution. Basic Qualifications Doctorate degree with 2 years of regulated labeling, medical device, combination product, instruction design, Human Factors, or related experience. Master’s degree with 6 years of relevant experience. Bachelor’s degree with 8 years of relevant experience. Associate’s degree with 10 years of relevant experience. High school diploma / GED with 12 years of relevant experience. Minimum of 2 years’ experience directly managing people and/or leading teams, projects, or programs. Preferred Qualifications Demonstrated people leadership, coaching, performance management, and career development experience. Experience leading FTEs, external workers, contractors, vendors, or matrixed contributors in a regulated or quality‑sensitive environment. Experience in regulated medical product labeling, artwork, packaging, Human Factors, or related fields; combination product experience preferred. Process improvement experience, including SOP implementation, template and checklist development, and functional scaling. Ownership or governance of controlled procedures, implementation, adherence, training, inspection readiness, and continuous improvement. Knowledge of IFUs, instructional materials, 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 skills, including defining expectations, monitoring performance, and resolving quality or timeline issues. Strong cross‑functional leadership, influencing skills, and the ability to align stakeholders across technical, regulatory, quality, operational, and design perspectives. Ability to manage multiple priorities, identify risks, and drive decisions in a matrixed environment. Strong written, verbal, facilitation, and executive communication skills. Demonstrated ability to translate customer, patient, user, and business needs into practical operational improvements. Lean, Six Sigma, process excellence, change management, or operational excellence experience preferred. Benefits Competitive base salary and a Total Rewards Plan that includes health, dental, and vision coverage; life, disability, and flexible spending accounts. Retirement and Savings Plan with generous company contributions. Discretionary annual bonus program and stock‑based long‑term incentives. Award‑winning time‑off plans and flexible work models when possible. Career development opportunities and commitment to professional growth. Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or any other status protected by law. We will provide reasonable accommodation for applicants with disabilities and request their assistance to do so. #J-18808-Ljbffr Amgen Inc. (IR)