Head, R&D QMS Documentation & Knowledge Management

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Job Description

OBJECTIVES/PURPOSE:
• Drives continual improvement and documentation and training excellence for R&D and R&D Quality, leveraging best-in-class industry standards, innovative approaches and new technologies
• Owns and champions the learning and documentation processes within R&D and R&D Quality and is a key enabler within the Quality, Compliance & Systems Team for overall QMS owner-ship
• Directs and manages a team responsible for the life cycle management and ownership of R&D QMS documentation and training

ACCOUNTABILITIES
• Establishes and leads an innovative learning infrastructure across R&D, including targeted learning programs, a continuous learning framework, training design, etc.
• Leads and drives cross-functional strategic projects in the documentation, training and QMS space, with impact on the entire R&D function, e.g., changes driven by process transformation or process improvement
• Ensures SME level knowledge and support of Takeda’s LMS/DMS enterprise systems including ensuring a contemporary overall view of R&D Quality documents
• Partners closely with Global Quality to ensure key initiatives are supported and driven to completion

RESPONSIBILITIES:
• Contributes to the design, development, and implementation of R&D learning programs, including document controls, LOC and supplier distribution, learning management system (LMS) administration, curricula design and management, and end user support
• Champions effective R&D QMS and Global Quality QMS linkages for Takeda’s Quality Standards and controlled documents (SOPs, TOOLs, FORMs), ensuring clear ownership and effective collaboration.
• Ensures that trends related to training, procedures and other QMS documentation identified in audits and inspections are addressed and promote continual improvement
• Owns the LMS and DMS processes within R&D Quality and partners directly with R&D Quality functional areas (Research, Clinical, Pharmaceutical Sciences & Devices, Cell Therapy and Pharmacovigiliance) to develop robust and effective training content.
• Works closely with R&D functions to ensure R&D QMS documents and training products are designed, developed, and distributed effectively, and meet all applicable regulatory requirements
• Provides process and system training on activities related to the R&D process excellence, documentation and learning programs
• Provides guidance on documentation and learning best practices for internal and external stakeholders
• Supports internal and external audits and regulatory inspections as needed, and maintains supportive documentation for the QMS Documentation & Knowledge Management Team (e.g., storyboards, overview presentations, etc.) DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
• Experience in leading learning projects and/or programs for a large and diverse audience
• Knowledge and experience working in a regulated environment (e.g. Bio-Pharmaceutical Research, Development, or Manufacturing/Technical Operations)
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
• Ability to lead effectively through directing change as well as driving change by influence
• Ability to lead and engage across the globe, with both internal and external stakeholders
• Ability to lead and implement communication, training, performance support strategies and tactics
Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem solving)
• An active member of R&D Quality Leadership team
• Responsible for informed decisions within the documentation and learning process space and is a key contributor for decisions within the overall R&D Quality QMS.
• Responsible for active and timely escalations based on a risk management principles
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
• Key interactions with all global R&D and Global Quality Compliance & Systems
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• BS/BA degree required; Advanced degree considered in pharmaceutical, medical or engineering (MSc, PhD)
• 10 years of pharmaceutical industry experience, with increasing managerial responsibility and matrix leadership in a global R&D/R&D Quality environment
• Experience must include 8 years of managing Quality Systems in a pharmaceutical or bio-technical field including DMS/LMS, QMS documentation and training, regulatory intelligence, etc., and 5 years of relevant experience in managing global teams
• Expert knowledge of DMS/LMS concepts and solutions
• Demonstrated ability to interface with senior leaders and cross-functional teams, and strong proven ability to influence and drive change
• Experience in managing complex organizational challenges and identifying and implementing organization-wide strategic initiatives and priorities
• Experience in operating in a multi-disciplinary drug development environment, including inter-national exposure and experience in a variety of therapeutic areas.
• Excellent written and verbal communication skills and fluent in written and spoken English
• Demonstrated ability to effectively manage multiple priorities with a sense of urgency

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EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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