Head of Commercial Vaccines Quality, Japan

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Job Description

OBJECTIVES/PURPOSE

• The Head of Quality leads the Quality Organization, develops, and deploys the Quality Strategy and Quality Systems for the vaccines manufacturing site, based on global Takeda and site Quality Standards.
• Provides leadership and oversight to all site Quality functions, and continuously develops people and teams.
• Ensures compliance with cGMP/GLP/GDP and drives Proactiveness and Continuous Improvement as well as Quality Culture of trust and speak up at the site.
• Ensures suitability and effectiveness of the Quality System by periodic Quality and Risk reviews with executive management
• Ensures quality, safety and compliance of vaccines products for disposition to local market.
• As a member of the Site and VBU Q Leadership Team, partners with all functions to achieve the site's & Business units Objectives.

SCOPE

Leadership/People:

No. of direct reports: 3-5

No. of indirect reports: 10-20

Geographic Scope:

Manufacturing site Hikari and Market, Japan

This position is responsible for quality oversight for manufacturing and distribution of vaccines commercialized in Japan.

ACCOUNTABILITIES

• The role is accountable for the overall quality strategy and quality management system of commercial vaccines operations and supplies in Japan. The Head of commercial Vaccines Q is responsible to design, deploy, monitor and improve the quality management system and for compliance to current Good Manufacturing/Distribution & Laboratory Practices and  compliance to Takeda global standards and overall Hikari Site Standards.
• The Head of commercial Vaccines Quality partners with the GMS site quality head and aligns on site quality strategy, a harmonized cross-plant quality philosophy & joint quality initiatives and maintains good day to day collaboration between the 2 site quality organizations.
•  Ensures new/revised quality system requirements are deployed to the site timely.  Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually execute compliantly & improve on site processes.
• Responsible for Japan vaccine quality performance, continuous improvement and Q-metrics (KPI) monitoring to ensure global and site targets are achieved, met and countermeasures in place when applicable.
• Responsible for Quality Control testing and sampling for commercial vaccines (BDS, DP) and partners with other Takeda laboratories or external laboratories for testing that is performed on behalf of vaccines quality (eg. Microbiology, Environmental Monitoring, Raw Materials)
• Responsible to establish the appropriate quality oversight for outsourced activities such as testing as well as quality assurance review of site validation activities.
• Development and refinement of groups’ specific quality systems and procedures.
• Committed to continuous improvement and responsible to proactively mitigate current and future risks to maintain an effective operation to support business needs.
• Living Takeda’s values (Takeda-isms) and fostering a Quality Culture culture of trust and and speak up culture within the team.
• Assuring appropriate GMP and QA systems training of Quality personnel and continuously develop team´s capabilities and expertise.
• Accountable for quality oversight of site quality management systems (CAPAs, Change Controls, Deviations, Formal Risk Management, facility/equipment/process qualification)
• Responsible for site specific QMR management and gathering of APQR data.  Align with GMSGQ team and provide QA support for electronic system integration: LIMS, Trackwise, SAP etc.
• Responsible for vaccine batch disposition decisions taking into account all relevant information and escalation processes.  Oversight of execution of product disposition (drug substance).
• Responsible to ensure sufficient and adequate quality oversight of vaccines manufacturing and distribution processes.
• Preparing for/ supporting/ leading internal and health authority regulatory inspections and third-party audits, including communicating with and providing information to regulatory submissions or bodies.
• Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity/training, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group.
• Responsible for management of cross-plant quality issues and timely escalation of vaccines related issues within the global Takeda VBU organization.
• Responsible for budget planning and managing expenses and for timely hiring, training and development of qualified staff to ensure effective execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Knowledge and experience of Biologics manufacturing
• Knowledge and understanding of Health Regulations applicable local and other markets supplied
• Knowledge and understanding of industry, scientific and regulatory trends, established products portfolio and market conditions to evolve Takeda’s regulatory and quality profile
• Strong analytical and problem-solving skills (preferably Lean & 6Sigma background).

Leadership

• Ability to lead a Quality organization of internal manufacturing with full accountability for all aspects of performance of respective site (Customer Service Levels, GMP compliance, EHS compliance, Opex Cost Savings, lab transformation, People Culture & Change)
• Ability to build a customer & patient-centered, best in class organization, develop diverse talent and elevate organizational performance
• Ability to make and recommend Quality decisions impacting Market Actions etc enabling Takeda to deliver on its commitment to put patients first and build trust with society.

Decision-making and Autonomy

• An active member of Site Leadership teams and vaccines quality team
• Responsible for decision making that balances progress on global initiatives with local priorities
• Responsible for Vaccines Quality governance (Quality Councils / Management reviews)
• Responsible for active and timely Incident notifications and associated escalation activities
• DOA limits to be defined in line with new TMAP

Interaction

• Key stakeholders include global & Japan VBU, GMS site Q, Procurement, Supply Chain, Regulatory Affairs.
• Local Board of Health Agency, National Control Laboratory

Innovation

• Unique contribution of thought, experience, background, and skills in operational excellence and quality

Complexity

• Diverse manufacturing technologies supplying local market

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Academic Background

• Scientific or engineering graduate (as applicable per country) (BSc, MSc, PhD).

Languages

• English: Fluent written and spoken
• Japanese: Fluent written and spoken

Experience

• Between 12 - 15 years of management experience in Quality in a GMP environment in the Pharmaceutical Industry,  minimum of 5 years of vaccine QA leadership experience.

Specific Knowledge

• Advance knowledge of good manufacturing practices in Japan its various guidelines as well as international standards such as FDA, EMA, PICS, WHO, USP, JP, EU Pharmacopeia etc.
• Should be current in knowledge of state-of-the-art processes and systems related to production as well as quality control of the products, including Digital/Automation concepts

Mandatory Certifications

• Leadership ability, decision-making, resilience and development of people and teams.

Behavioral Competencies:

• Ability to focus on few key priorities and demonstrate strategic enterprise thinking
• Ability to deal with ambiguity
• Patient and customer-centric
• Very strong ability to drive and manage change
• Experience leading teams in an highly regulated environment
• Ability to inspire and build trust within team and across network
• Strong analytical abilities in order to make competent decisions based on the review of data
• Strong attention to detail in regards to data integrity, data collection and data analysis

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.

Locations

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