About The Job
External Manufacturing & Supply General Medecine Japan - Quality (EMQA JP) is the Quality Unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi Japan (SAKK) products.
EMQA JP staff interacts with functional units within SAKK, Sanofi sites, and other organizations within the EM&S network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediate (e.g. API, drug substance) and finished products with minimal risk to quality or prodEuct supply.
We deliver billions healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our External Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as
QA Manager
will be to drive continuous improvement in CMO manufacturing by managing a portfolio related activities and providing support to CMO management activities like Change Control Requests, leading deviation investigations, and using your findings to deliver positive change.
Main Responsibilities
Quality Operations related to manufacturing and release of Sanofi Products :
Act as CMO Quality site contact and responsible for CMO quality oversight for QA operations. Quality representative actively engaged in internal core team meetings and joint meetings with the CMO. Responsible for quality oversight of cGMP documents and records (includes but not limited to: batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements): responsibility includes ensuring applicable documents/records receive the appropriate level of Sanofi SME review in accordance with requirements of Sanofi procedures and standards
Responsible to review and approve documents in the QA capacity
Responsible for product release in accordance with approved specifications and procedures Monitor contractor performance to established key performance indicators (KPI) and report and escalate adverse trends. Demonstrate understanding of applicable health authority regulations related to manufacture of sterile and non-sterile products
Operational Support of CMOs management and Project management
QA Manager in EM Japan are responsible for Quality oversight on all pharmaceutical related activities to ensure compliance in respect to the GxP, the marketing authorization, and all applicable procedures.
Following the main responsibilities as defined above the QA Manager provides support and contribute when requested to operational management of CMOs
Support the internal quality activities of EM&S
QA Manager participate in maintaining EMQA JP Quality systems, documentation and internal activities such as, but not limited, Budget overview, Site Quality Review, Self Inspection.
About You
Education and Experience:
Degree in Pharmacy or Chemistry and at least 5 years of experience in biopharmaceutical manufacturing or QC/QA.
Experience in CMC Regulatory is highly welcomed.
Experience in sterile is highly welcomed
Soft And Technical Skills
QA experience: understanding of GMP/GQP/GDP, experience in validation (process, analytical, shipping), batch record review, product release.
Knowledge of biological manufacturing (cell culture, sterile).
Familiarity or experience in reviewing Japanese dossier.
Experience in communicating with Japanese health authority.
Attentive to details
Good communication and negotiation skills to manage stakeholders (authorities, affiliate, CMO, regulatory, etc.)
Open and eager to learn new challenges.
Languages
Native Japanese
Business level English
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