【大阪】Lead or Manager, Quality External Operations Japan/APAC

[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. 

[Job responsibilities & Expectations]
• This position has responsibility for Quality Assurance, and support of Quality Control, for external Small Molecule and Oncology Contract Manufacturing Organisations  (CMOs), Suppliers, located within the Japan and Asia region, inclusive of Drug product, QC testing, pack-aging and labelling activities.

• The role holder will establish the strategy and plans for the Quality External Operations Japan/APAC team organisation to meet the Global Quality and Small Molecule and Oncology (SM&O) Operating Unit vision and objectives, establish priorities, build a regional patient-centred best in class organisation, develop di-verse talent and elevate organisational performance, and execute on Quality improvement projects, and where appropriate, manage the finances of the team.

• The role holder is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the SM&O Operating Unit, and other External Operations regions, with Takeda manufacturing sites, Takeda Local Operating Companies (LOCs), and external partners.

[Required Qualifications]
Relevant experience:
• Minimum of 12 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
• 10+ years of increasing management responsibility combined with strong technical operations background.
• Broad understanding of global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of Japan GMP, EU/US GMP, ICH, and other relevant regulations.

Education:
• Minimum of Bachelor’s Degree in Pharmacy, Chemistry, Biology or related discipline.

Technical Skills:
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
• Leadership – ability to effectively lead and motivate a team of direct reports, provide a unifying vision, build on strengths, and address areas for improvement.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management.
• Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
• Regulatory understanding – broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing and packaging.
• Excellent intercultural communication, negotiation, and practical problem solving skills.
• Cross functional and matrix management. Preferred experience in large, multi-national, matrixed organizations.

Languages:
• Fluent in written and spoken English.

[Preferred Qualifications]
Relevant experience
• At least 6 years of direct people management experience is desired.

Technical Skills
• Project Management expertise