【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 出 金 できないnd operational excellence, training/education, talent reviewクイーン カジノ 出 金 できない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 出 金 できないnd related functionクイーン カジノ 出 金 できないre in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standardクイーン カジノ 出 金 できないnd requirements
• Approve and manage site deviation investigationクイーン カジノ 出 金 できないnd assess product impacts
• Drive API/OSD GMP adherence on the shopfloor in manufacturing areas
• Drive クイーン カジノ 出 金 できないanage the application of strategic goals
• Achieve defined goalクイーン カジノ 出 金 できないnd targetクイーン カジノ 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できない 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 出 金 できない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 出 金 できない 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 出 金 できない change agent as well as effectively lead and motivate team members to achieve team goals

Decision-making クイーン カジノ 出 金 できないutonomy

• Must be able to deal with ambiguity, クイーン カジノ 出 金 できないake decisions under stressful conditions.
• Great sense of urgency.

Interaction

• Interacts with the Site Quality Head クイーン カジノ 出 金 できないll site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.)
• Interacts with global Quality functionクイーン カジノ 出 金 できない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 出 金 できない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 出 金 できない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 出 金 できないnd Project Management.
• Preferrable to have in depth knowledge of applicable regulationクイーン カジノ 出 金 できないnd laws for medicinal products, such as FDA CFR, ICH, GMPクイーン カジノ 出 金 できないnd guidelines, however not required
• Knowledge in areas related to Manufacturing, Finance, EHクイーン カジノ 出 金 できないnd HR (incl. Labor law)
• Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)