**Position Details** + **Department** : External Manufacturing and Supply Gen Med Quality Assurance Japan + **Job Title** : Quality Manager + **Location** : 50% Tokyo, 50% Kawagoe City + **Reports to** : Head Quality Operations, External Manufacturing & Supply Japan + **Supervises** : None (Direct & Indirect) **Purpose** To ensure quality oversight of a strategic Contract Manufacturing Organization (CMO) and support quality-related activities of External Manufacturing & Supply (EM&S) Japan. **Key Responsibilities** **Oversight of CMO Quality Operations** **(90% weightage)** **Quality agreement:** Ensure and coordinate the update of the QTA with the CMO and related PTS in collaboration with the Sanofi QA managers in charge of the QTA management and change control management. **Audit/inspection:** Review the Sanofi CMO audit report Follow-up the CMO audit capa implementation Support the regulatory inspection of the CMOs Ensure the capa plan is defined and in place to address the inspection findings. **KPIs and CMO performance assessment:** Ensure the data collection of the KPIs defined in the Quality agreement Contribute to the CMO risk ranking in collaboration with the other EM&S JP stakeholders. Define in collaboration with the EM&S Quality Head and conduct the mitigation plan depending on the risk ranking outcome. **Quality review** Lead the periodic quality reviews with the CMO Ensure the follow-up of the actions defined during the quality reviews. Support the business reviews (quality part) **Deviation Management** Support the CMOs in the classification of their deviations to be reported to Sanofi. Perform the coordination of any urgent quality events in collaboration with the EM&S JP stakeholders. Contribute to the investigation and follow-up of the deviations reported to Sanofi in collaboration with the EM&S QA manager in charge of the deviation management. Ensure that the CMO CAPAs are defined and implemented and the associated efficiency review in place. **Change control management** Ensure that the change actions assigned to the CMO are performed in a timely manner. **Validation, transfer of products** Ensure that the CAPA actions assigned to the CMO are performed in a timely manner. Identify the need of validation/revalidation in collaboration with the EM&S Quality managers responsible for change control management, PQR management, transfer/new launch. **Risk Management** Proactively identify the risks linked to the compliance of the CMO activities Contribute to the escalation of the quality events linked to the CMO activities. Contribute to the definition of the mitigation plan of the risk. **Stability** Ensure that the CMO stability program is available Collect stability data from the CMO Contribute to the stability data tracking and trending done by other EM&S stakeholders. **CMO compliance:** Ensure the CMO compliance to any new regulations or Sanofi directives. **Support Internal Quality Activities of EM&S** (10% weightage) **Budget overview:** Request quotation for the quality activities to the CMO when appropriate. Ensure the follow-up of the PO. **Site Quality Review:** Contribute to the EM&S JP quality review **Self inspection:** Contribute to the self inspection of EM&S JP quality **Pre-requisites** + **Knowledge, Skills & Competencies** : + Manufacturing process and compliance + GQP/GMP Compliance + Manufacturing/Laboratory Investigations + Change control and Deviation Management + Quality Risk Assessment (QRA) + Nitrosamine Impurities management + ICH Q1-Q3 + Visual inspection + Sterility assurance + **Languages** : Fluent in English and Japanese **Qualifications** + Ph.D. in Pharmacy or Chemistry + 10 years of experience in manufacturing or QC/QA in pharmaceutical **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)