Head of Non-Sterile Quality Assurance, Hikari Site (Director)

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About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of our company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.  

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in that order. 

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 strategies and operational excellence, training/education, talent reviews and personnel development
• Responsible for all aspects of API/OSD/Warehouse Quality Assurance at the facility, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standards and requirements
• Approve and manage site deviation investigations and assess product impacts
• Drive API/OSD GMP adherence on the shopfloor in manufacturing areas
• Drive and manage the application of strategic goals
• Achieve defined goals and targets at 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 expenses and 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 actions as needed to ensure timely delivery of those goals
• Lead and ensure consistency in Deviation Investigation processes
• Drive and manage Shop Floor QA activities, change control and validation execution
• Manage warehouse support and pest control
• Drive and lead Data, Digital, & Technology (DD&T) and AGILE programs in the Quality organization to be future ready
• Drive and lead new ways to improve and streamline current business and 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

DIMENSIONS AND 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 risks associated with product quality or regulatory violations
• Excellent verbal and written communication skills in English. Japanese language skills a 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 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 Takeda leadership behaviors throughout the Global Quality 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

• 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 “Quality 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 COMPETENCIES AND 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 Systems and Project Management.
• Preferrable to have in depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines, however not required
• Knowledge in areas 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.)

Preferred

• Licensed pharmacist
• MBA
• Experience  overseas
• Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety.
• Preferred to have experience in ISO 14001/45001 management system
• Some travel will be required.
• This job description is not designed to be a complete list of all duties and responsibilities

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.