Seoul, KOR
2 days ago
External Manufacturing and Supply Specialty Care Large Molecules, Principal Operations Lead
**Internal 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 **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) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) 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)
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