1+ months

[UPJ] Director, Supply Chain Quality Japan Lead


+ English **Organization** UGS, Supply Chain Quality **Job Title** NA Director, Supply Chain Quality Lead **Reporting Line** **( Position)** Sr. Director / UGS-J, Pfizer Japan **Position Purpose** The role will be accountable for establishing and managing the Supply Chain Quality organization for two legal entities, authorized generics and branded products for Upjohn in Japan to ensure product quality and inspection readiness. The business licence and the companies right to operate will be maintained at all time. This includes the lead of a team with currently five headcounts and the coordination with 3 resources under the TSA with Pfizer Japan to support the implementation of and compliance to SCQ Global SOPs, any other Pfizer Upjohn Quality Standard requirements and the local legislation in Japan, including GDP. Product release to the market will be managed for the Upjohn product portfolio currently consisting of more than 180 SKUs and accounting for an annual revenue of 1,300M USD in 2020 with Japan being one of the most important markets for Upjohn/Viatris. The incumbent will act as primary contact for product quality matters for other functions, including business partners, local and regional Regulatory, PV, Supply Chain, Business Units and Medical and, in the role of the legally mandatory Chief Quality Officer for PU GK, towards the inspection unit of the PMDA, the Japanese Board of Health. Moreover, the position holder will cooperate with the Chief Pharmaceutical Officer to maintain MA licenses (MAH) and correspond to authorities appropriately. The incumbent will be responsible for the Quality oversight of Local Service Providers including three Distribution Centers covering product supply across the country, the SCQ budgets and for the organization and development of the team reporting into the position. ** Description of Primary Role & Responsibility** Cooperate with the (Chief Pharmaceutical Officer) to appropriately maintain MA license (MAH) and correspond to authorities appropriately and comply with regulations (J-PAL, GQP, QMS, GDP guideline). Properly manage local service providers and assure product quality Handle product release to the market and deviations after release, respond to Japanese pharmaceutical Laws, and supervise the quality unit in DC (GDP guidelines) Maintain and manage an appropriate quality system in accordance with the Global PGS Quality Assurance Standard (PQS). Cooperate with PGS, CPO, JDSU, MI, Regulatory to take quality responsibility Educating team members and encouraging the talent development Proper and budget control to make activities of SCQO Japan for efficient and effective Making effort to realize UGS and UGS Japan vision and promote corporate culture Keep good relationship with internal and external stakeholders to realize Patient First **Desired Behavioral and Technical Skills** 1. Behavioral Skills Demonstrate Pfizer Values, activate OWNIT cultures, and is committed to One Pfizer. **Excellent organizational, interpersonal and communication skills** to work smoothly with people inside and outside PGS Japan. 2. Technical Skills **In-depth working knowledge of cGMP, EU-GMP, J-GMP, GQP, QMS and Pfizer Quality Standards.** Ability to keep proper balances between quality/compliance and cost.

+ 3. Experience

+ Enough knowledge and experience on pharmaceutical manufacturing and quality operations.Demonstrated ability to work in a matrix environment.

+ 4. Education Certification

+ Have educational background in science, chemistry, or pharmacy.

+ 5. Language

+ Have a good communication skill in Japanese and English. (TOEIC score 730) **Organizational Relationships** Pfizer Global Internal All the departments in PGS-J, GQO, GTS, GCMC, WBB/ CQSA, JDSU, MI, Marketing, sales External **** **Tokyo Metropolitan Government/ PMDA/ MHLW/BSI/Aichi pref.b** **BoH of foreign countries** **CMOs and contract laboratories** **Related Laws and Regulations** Japanese Pharmaceutical affairs Law (GQP, QMS, GDP Guideline & GVP) Japan Pharmacopeia GMP (J-GMP, cGMP, US, EU-GMP)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control


Posted: 2020-09-14 Expires: 2020-10-29

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[UPJ] Director, Supply Chain Quality Japan Lead


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