DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
・Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines.
・Knowledge in Plasma Derived Therapeutic processes including sterile operations and packaging operations.
・Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
・Excellent verbal and written communication skills in both Japanese and English.
・Adaptive communication and presentation skills to effectively reach different levels, including senior management.
・Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
・Experience/expertise with TrackWise Deviation/CAPA and SAP systems.
Leadership
・Strong leadership skills and demonstrated success in managing a team.
・Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, egender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.
・Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Narita Plant.
・Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
Decision-making and Autonomy
・Must be able to deal with ambiguity, and make decisions under stressful conditions.
・Great sense of urgency.
Interaction
・Interacts with the Site Head and all site functions (Business Excellence, EHS, HR, Finance, IT, Manufacturing, Engineering and Supply Chain)
・Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators.
・Interacts frequently with subordinates, functional peers, and the Senior Leadership Team.
Innovation
・Strong knowledge of Quality Risk Management principles.
・Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
・Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business.
・Lead and engage employees by initiatives of “Qualtiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements.
Complexity
・Key stakeholders include but not limited to: Quality System & Compliance, Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovisilance, Regulatory Affairs, and Health Authorities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
・Bachelor’s degree or graduated technical college in Chemistry, Pharmacy, Engineering, Biology or related discipline.
・At least 5 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality system & compliance, Quality Control; understanding of the requirements for manufacturing, plant utilities, computer systems and project management.
・In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
・Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law)
・Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
Preferred
・License for pharmacist
・Business level of English skill is necessary (both verbal and written)
・MBA
・Experience of overseas assignment.
・Experience in managing team with applicable perspectives
・Experience in ISO 14001/45001 management system to carry out continuous improvement of site.
■職種未経験者:不可