The position will be based in our headquarter offices located in San Diego, California and reports to corporate Quality Assurance. S/he will be accountable for adherence to Illuminas corporate training and development policies and procedures governed by the Illumina Quality Management System.
The Senior Manager of Training shall develop, deploy, and maintain strategic initiatives supporting the Global Quality & Operations organization, and assure global alignment with cross-functional sub-groups. As Illumina continues to grow and expand into global, commercial clinical markets there is a need to establish training solutions that demonstrate compliance to applicable internal and external guidelines and requirements.
Tasks and Responsibilities: Partner with Product Development, Commercial, Human Resources, and Safety organizations to align corporate policies (curricula, tools, media) Consolidate and harmonize, as feasible, global training and development processes to drive quality through consistency of execution with assurance of effectiveness. Define and champion improvement projects in alignment with corporate initiatives and values. Define and implement key performance indicators and report results (i.e. metrics and reports) to senior and executive management; examples include training program compliance and effectiveness. Function as a subject matter expert during internal and external audits (e.g. customer and regulatory) Manage personnel and functions responsible for development and delivery of local, regional, and global training content and resources. Manage personnel responsible for administration and maintenance of Illuminas Learning Management System (LMS); SABA. Interact with Global Information Services personnel and cross-functional stakeholders to champion periodic technology enhancements. Collaborate with functional leads to design and develop enhanced GxP training packages, training schedules, interactive assessments, and competency-based evaluations Apply best practice in accelerated learning techniques and content delivery (e.g. instructional design, adult learning theory, facilitation and other relevant training methodologies) to ensure value-added learning & development for our customers Engage New Product Introduction (NPI) teams to align training requirements expected to meet critical program milestones. Identify opportunities for improvement, relative to GxP manufacturing requirements and expectations, and drive project-based initiatives to achieve pre-defined results. Define and implement corrective and preventive measures (e.g. CAPA) based on audit results and/or process evaluations. Demonstrate superior communication and listening skills, working with all levels of organizational structure (e.g. staff, colleague, and executive management), through multiple departments (e.g. technical and operations), and across global sites sourced in Europe, Asia, and throughout North America.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Experiential Background: Minimum 10-12 years of related experience, preferably in a GxP environment Minimum 5-8 years of experience managing personnel required; project management may be considered in lieu of department/team management Thrives in a culturally fast paced & dynamic environment Demonstrated high performance leader championing change initiatives of various size and complexity Demonstrated project management experience and skill-set required FDA auditing experience or exposure, preferably in diagnostics and medical device Ability to translate complex into simple and formulate quality solutions aligned with strategic business initiatives Working knowledge of applicable federal requirements, and international standards for in-vitro diagnostics and medical devices Excellent verbal and written communication skills, including presentations to executive level management Strong data analysis skills Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work
Educational Background: Requires a Bachelors degree in a relevant discipline. Professional training and/or advanced degree (e.g. Instructional Design, Education, Business, ProjectManagement) strongly preferred.
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