Narita Site Quality Head
Takeda
Narita, Japan
1 時間前

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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

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