GxP/ non-GxP Learning Lead, Business Excellence, Japan Plasma New Facility Program (Associate Director or Manager)

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Job Description

About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

Summary

We are looking for a motivated and skilled individual to lead Business Excellence learning for TOPS. This key role involves creating a learning system to improve performance and ensure compliance with Global training standards, aligning with our strategic goals. Reporting to the Head of Business Excellence, the successful candidate will develop a learning plan based on training needs analysis to meet operational competency requirements in a GXP regulated manufacturing environment across various functions and implement the GMS learning strategy according to site needs and business objectives.

Essential Duties and Responsibilities

• Develop and maintain the site Learning system to build and enhance performance capability and ensure compliance with Global standards for training within GMSGQ
• Responsible for establishing the site learning plan, based on robust training needs analysis to deliver the operational competency requirements for a GXP regulated, manufacturing environment across multiple functions and for implementing the GMS learning strategy based on site needs and business objectives
• Oversee the implementation of global Training policies and GOPs to ensure an efficient, effective and compliant learning system is in place to meet site needs
• Responsible for managing the continued deployment and use of LMS platforms, including administration and delivery applications
• Works with their assigned Global Learning Team Business Partner to ensure robust Learning system elements are in place and appropriate technical learning solutions are provided for site’s use
•  Foster strong collaboration with enabling teams and key stakeholders, ensuring alignment of priorities and integration of ongoing feedback.

Qualifications

• Assess training needs across functions to develop and deliver site/project learning plan to meet performance needs
• Manage the development and implementation of learning strategy, based on the GMS Learning Strategy, including creating technical competency and career maps
• Ensure overall development and integration of training curricula and programs and measurement of learning effectiveness
• Monitor and evaluate the effectiveness of core training programs and ensure programs are continuously improved
• Provide technical expertise and resources in the design, development and implementation of new learning programs required based on technical competency maps
• Manage internal and external partners and suppliers, along with training and development budgets related to specific initiatives
• Partner with GMS Global Learning Team to assess and improve site learning system based on results from Learning System Maturity Assessment or similar
• Serve as site representative on GMS Global Learning Forum and partner with site or center Training Leads to prioritize key learning interventions in support of customer requirements and evolving Regulatory requirements
• Evaluate the effectiveness of training initiatives at satisfaction, activity, and business outcome levels across all businesses
• Leverage and continuously improve technology for effective learning solutions to managers and employees
• Develop learning plans and any associated budgets to deliver agreed business results
• Supervise project learning team (if any)
• Drive Training Process and Technology re-engineering, innovation, strategy and culture changes – areas of focus include learning analytics, piloting technology for virtual and augmented reality and opportunities for live video link up between OpU/Network sites for remote on-the-job training and coaching, where relevant
• Introduce and integrate Right First Time Culture & Behavior/Human Performance thinking / culture for the site, looking at trending of data for enhanced human performance and elimination of hu-man error through performance coaching
• Oversee transition to Risk based training assignments and reduction on dependency on SOP read & sign in favors of competency based training approaches and accreditation of prior learning (APL)
• Represent and defend learning programs during regulatory and / or internal audits and inspections collaborating with QA
• Network and benchmark internally and externally to drive improvement and consistency for the site learning system
• Maintain currency of learning proficiency through research of new learning methods and materials to enhance our effectiveness
• Manage and report site training metrics internally within the site and to global Quality partners collaborating with QA
• Manage or oversee the administration of Learning Management System (s) (LMS) working closely with QA
• Coach OJT trainer to improve the consistency and effectiveness of on the job training across all shifts and areas of the business for performance enhancement

Education and/or experience

• SME on Learning Systems/Process development and implementation, including performance consulting, coaching, program design and learning methodologies
• Effective communication skills at all levels of the organization
• Flexibility and ability to assimilate new knowledge and standards quickly
• Excellent organizational and coaching skills essential
• Leadership (vision, strategy and business alignment, people management, communication, influencing others, managing change)
• Develop and execute site learning strategies
• Influence people at all levels in the business – demonstrated ability to influence at all levels
• Demonstrated ability to coach and develop others

*Takeda expects all employees to embody the following:

• Values – Integrity, Honesty, Fairness, Perseverance
• Priorities – Patient, Trust, Reputation, Business

Physical Demands

• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment
• Must be able to work overtime as required (APPLICABLE TO SNE only).
• May be required to work in a confined area.
• Some clean Room and cool/hot storage conditions

Other Job Requirements

• ​ Availability to travel as neededto coordinate with various stakeholders.

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

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