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OBJECTIVES / PURPOSE
Oversee and lead all quality efforts in Narita site, including the development and implementation of quality system for supplying quality products from Narita site.
Cultivate quality culture and have it penetrated into Narita site.
Provide strategic vision and overall leadership to Narita site QA and QC organization.
ACCOUNTABILITIES
Design, lead and manage the Site QA and QC organization to ensure GMP compliance in Narita site.
Achieve productivity and efficiency improvement targets in Narita Site Quality through Laboratory Excellence with Program AGILE for lean Quality organization.
Foster and qualify talents in Narita Site Quality with their career plan for sustainable growth of the organization.
Plan CAPEX and cost budgets and execute these as planned for Narita Site Quality.
DIMENSIONS AND ASPECTS
Technical / Functional (Line) Expertise
Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines.
Knowledge in API, parenteral technology, plasma derived therapy, biologics or combination products.
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.
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, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.
Leadership
Strong leadership skills and demonstrated success in managing a team.
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender 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 Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.)
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 " "Digital" to drive continuous improvements.
DIMENSIONS AND ASPECTS
Technical / Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)
Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines.
Knowledge in API, parenteral technology, plasma derived theraphy, biologics or combination products.
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.
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, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.
Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
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 (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)
Must be able to deal with ambiguity, and make decisions under stressful conditions.
Great sense of urgency.
Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.)
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 (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
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 " "Digital" to drive continuous improvements.
Complexity
Key stakeholders include but not limited to : Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :
Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.
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 ( Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
Business level of English and Japanese skill is necessary (both verbal and written)
Preferred
License for pharmacist
Experience of overseas assignment.
Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety.
5 years for department head and 3 years for Group Managers)
Preferred to have experience in ISO 14001 / 45001 management system to carry out continuous improvement of site.
ADDITIONAL INFORMATION
Some travels will be required.
This job description is not designed to be a complete list of all duties and responsibilities required of the position.
Location : 千葉県成田市 日本製薬成田工場へ出向
