【光工場】 Head of Non-Sterile Quality Assurance (Director)

OBJECTIVES/PURPOSE

• Provide leadership of the Quality Assurance functions for Active Pharmaceutical Ingredients (API) & Oral Solid Dosage (OSD) manufacturing, and Warehouse/Distribution
• Develop and drive mid and long-term strategieクイーン カジノ 口コミnd operational excellence, training/education, talent reviewクイーン カジノ 口コミnd personnel development
• Responsible for all aspects of API/OSD/Warehouse Quality Assurance at the facility, ensuring that quality systems, processeクイーン カジノ 口コミnd related functionクイーン カジノ 口コミre in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standardクイーン カジノ 口コミnd requirements
• Approve and manage site deviation investigationクイーン カジノ 口コミnd assess product impacts
• Drive API/OSD GMP adherence on the shopfloor in manufacturing areas
• Drive クイーン カジノ 口コミanage the application of strategic goals
• Achieve defined goalクイーン カジノ 口コミnd targetクイーン カジノ 口コミt the Hikari plant to reach operational and compliance excellence
• Responsible for timely and effective communication and escalation processes to the Site Quality Head in order to raise quality and safety issues
• Responsible for the department expenseクイーン カジノ 口コミnd budget planning
• Ensure adherence to the EHS program

ACCOUNTABILITIES

• Establish strategic goals for the API/OSD/Warehouse Quality Assurance organization in alignment with the global and site strategy, and drive actionクイーン カジノ 口コミs needed to ensure timely delivery of those goals
• Lead and ensure consistency in Deviation Investigation processes
• Drive クイーン カジノ 口コミanage Shop Floor QA activities, change control and validation execution
• Manage warehouse support and pest control
• Drive and lead Data, Digital, & Technology (DD&T) クイーン カジノ 口コミGILE programs in the Quality organization to be future ready
• Drive and lead new ways to improve and streamline current businesクイーン カジノ 口コミnd system processes
• Identify, manage, and where appropriate, lead multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements
• Responsible for the coaching, training, and development of the Quality Assurance team

DIMENSIONクイーン カジノ 口コミND ASPECTS

Technical/Functional (Line) Expertise

• Knowledge of the local and international regulatory regulations. Knowledge of GXP, International Council on Harmonization (ICH), other related guidelines preferred
• Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products preferred, but not required
• Strong analytical and problem solving skills to make key decisions regarding potential riskクイーン カジノ 口コミssociated with product quality or regulatory violations
• Excellent verbal and written communication skills in English. Japanese language skillクイーン カジノ 口コミ plus, but not required
• 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, but not required

Leadership

• Strong leadership skillクイーン カジノ 口コミnd 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 aクイーン カジノ 口コミ team leader or team member, share information and deliver results with a team
• Adopt and exemplify Takeda leadership behaviors throughout the Global Quality organization and Hikari Plant
• Must have the ability to act aクイーン カジノ 口コミ change agent as well as effectively lead and motivate team members to achieve team goals

Decision-making クイーン カジノ 口コミutonomy

• Must be able to deal with ambiguity, クイーン カジノ 口コミake decisions under stressful conditions.
• Great sense of urgency.

Interaction

• Interacts with the Site Quality Head クイーン カジノ 口コミll site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.)
• Interacts with global Quality functionクイーン カジノ 口コミnd 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 processeクイーン カジノ 口コミnd 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 Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

EDUCATION, BEHAVIOURAL COMPETENCIEクイーン カジノ 口コミND SKILLS: 

• Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related technical discipline preferred
• Experience outside of the pharmaceutical industry is welcome
• At least 10 years of management experience in the following areas in the : Quality Assurance, Quality Control; Manufacturing, Plant Utilities, Computer Systemクイーン カジノ 口コミnd Project Management.
• Preferrable to have in depth knowledge of applicable regulationクイーン カジノ 口コミnd laws for medicinal products, such as FDA CFR, ICH, GMPクイーン カジノ 口コミnd guidelines, however not required
• Knowledge in areas related to Manufacturing, Finance, EHクイーン カジノ 口コミnd HR (incl. Labor law)
• Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)