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Job Description
OBJECTIVES/PURPOSE
- Accountable for and oversee all quality efforts in Hikari site, including the development and implementation of quality system for supplying quality products from Hikari site.
- Cultivate and drive quality culture and have it penetrated into Hikari site.
- Drive and lead strategic vision and provide overall leadership to Hikari Site Quality organization (QA + QC)
- Develop and lead strategic and sustainable Quality organization including function of Quality Assurance, Quality System, Quality Compliance, Quality Service and Improvement, Quality Control, and Microbiology / Sterility Assurance.
- Role of Hikari GMP Product Security Pharmacist required by Japanese GMP regulation
ACCOUNTABILITIES
- Accountable for designing, driving and leading the Hikari Site Quality (QA and QC) organization to ensure GMP compliance at the site to contribute to the patient.
- Achieve productivity and efficiency improvement targets in Hikari Site Quality through AGILE program, Laboratory Excellence, and DD&T by adding quality value to contribute to the business.
- Drive quality culture foster, and develop qualify talents in Hikari Site Quality with their career plan for sustainable growth of the organization and to be trusted organization.
- Accountable for resource (HC) planning, quality CAPEX/OPEX planning and execute these as planned for Hiakri Site Quality.
- Drive and lead external engagement, and communication/collaboration with regulatory agency to improve Hikari Quality reputation.
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, solid dosage forms, parenteral technology, 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 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, 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, 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 Hikari 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 4.0" "Digital" to drive continuous improvements.
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- 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.
- At least 10 years of management experience in the following areas in the pharmaceutical industry: Quality assurance, 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.)
- Business level of English skill is necessary (both verbal and written)
Preferred
- License for pharmacist
- MBA
- 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
- Travels will be required.
- This job description is not designed to be a complete list of all duties and responsibilities required of the position.
Takeda Compensation and Benefits Summary:
Allowances: Commutation, Housing, Overtime Work etc.
Salary Increase: Annually, Bonus Payment: Twice a year
Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45
Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
Flexible Work Styles: Flextime, Telework
Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
It is possible the job scope may change at the company’s discretion.
It is possible the department and workplace may change at the company’s discretion.
