Job Information
Takeda Pharmaceuticals Head, Quality Systems & Compliance, Narita Site Quality in Chiba, Japan
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Job Description
Please note this job requires business level Japanese in speaking, writing, and reading.
About Takeda
”Better Health for People, Brighter Future for the World” is the purpose of a 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 this order.
OBJECTIVES/PURPOSE
Provide leadership of Quality Systems & Compliance functions. Develops and deploys mid and long-term plan with KPIs and operational excellence, training/education, talent review and personnel development
Managing aspects of Quality Systems & Compliance of drug substances and drug products 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.
ACCOUNTABILITIES
Manages the Quality Systems & Compliance organization making sure the site goals are cascaded into the department.
Ensure that quality related computerized systems including TrackWise and DMS/LMS are effectively implemented across the site.
Ensure that change control process is in place and all changes are appropriately assessed, necessary actions are taken and the changes are implemented.
Maintain validation programs and review and approve validation documents.
Manage and host overseas/domestic regulatory inspections or audits.
Create documents associated with manufacturing license and communicate with regulatory authorities.
Generate APQR associated with products in Narita and approve them.
Organize Quality Management Review and monitor and control Quality KPI/Metrics.
Investigate cause of customer complaints and create investigation reports.
Maintain supplier management programs and qualify suppliers/service providers.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines.
Knowledge in Plasma Derived Therapeutic processes including sterile operations and packaging operations.
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 Change Control/Complaint/Inspection and SAP systems.
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 the Takeda leadership behaviors throughout the GQ organization and Narita 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 Head and all site functions (Business Excellence, EHS, HR, Finance, IT, Manufacturing, Engineering and Supply Chain)
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 Assurance, 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 5 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality system & compliance, 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.
Experience in managing team with applicable perspectives
Experience in ISO 14001/45001 management system to carry out continuous improvement of site.
ADDITIONAL INFORMATION
Some travels will be required.
This job description is not designed to be a complete list of all duties and responsibilities required of the position.
What Takeda can offer you
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
Click here (https://www.takeda.com/en-us/corporate-responsibility/people/#DiversityEquity) to find out Takeda’s Diversity, Equity & Inclusion
Better Health, Brighter Future
Locations
JPN - Chiba - Narita Plant
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time