External Manufacturing and Supply Specialty Care Large Molecules, Principal Operations Lead
Seoul, South Korea Permanent Posted on Mar. 11, 2025 Closing on Mar. 31, 2025Internal Job Description
Department Description
External Manufacturing and Supply Specialty Care Large Molecule oversees drug substance, drug product, and finished goods manufacturing operations at our Contract Manufacturing Organizations (CMOs). As the main point of contact between Sanofi and our CMOs, you will ensure successful execution of manufacturing projects, foster strong relationships, and drive value to meet business objectives.
Position Overview with Key Responsibilities
Specialty Care Large Molecule Operations will work in partnership:
With External Manufacturing Product Teams (EMPT) members, EM&S business partners and CMO partners
Responsible for on time and in full delivery of products for CMOs/External Suppliers within EMPT unit, accountable for tracking of EMPT KPIs. Drives continuous improvement in the performance of the supplier in areas of Safety, Quality, Cost & Delivery
Responsible for all EMPT CMO operational activities including input into contract development and lifecycle management, CMO performance review and monitoring, CMO project oversight, Periodic Business Review and participation in site visits.
Responsible for on time delivery of Quality System related records. Participates in cross-functional team investigations into major and critical deviations.
Supports the EMPT products/CMOs from a financial perspective through the management of related activities against contract guidelines (MSA & QTA) including issuance of purchase orders, adherence to non-COGs budget.
Responsible to ensure identification, evaluation, and documentation of risks potentially impacting quality and compliance. Participates in multi-disciplinary teams to define remediation plans to mitigate risks impacting products and GxP Operations.
Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (GSC, MSAT, Legal etc). Coordinating team activities with EMPT Quality and Supply Chain team members to ensure full alignment within the EMPT.
Responsible for the successful project execution of Sanofi Tier 3 projects and CMO projects directly related to EMPT products.
Responsible for other activities, as needed
Leadership Qualifications
N/A
Basic Qualifications
Experience:
Bachelor’s degree with scientific background or equivalent and 5+ years of experience or Experience in operational roles, ideally as Site manager, SLT member
Good functional knowledge of industrial business processes
Good exposure to cross sites & cross GBUs networking is a plus.
Technical skills
Basic or good understanding of data management and IA digital products
Knowledgeable in E2E product & industrial strategy, performance management, project management and biotech/pharmaceutical industry technologies
Strong analytical skills.
Good command of KPI target setting & monitoring
Languages: Fluent English
Preferred Qualifications
Experience:
Bachelor’s degree with scientific background or equivalent and 5+ years of experience o Experience in operational roles, ideally as Site manager, SLT member
Good functional knowledge of industrial business processes
Good exposure to cross sites & cross GBUs networking is a plus.
Master’s degree with scientific background or equivalent and 4+ years of experience
Skills:
Basic or good understanding of data management and IA digital products
Knowledgeable in E2E product & industrial strategy, performance management, project management
Knowledgeable in biotech/pharmaceutical industry technologies
Strong analytical skills.
Good command of KPI target setting & monitoring
Languages: Fluent English
Special Working Conditions
Up to 20% Domestic or international travel
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