External Manufacturing and Supply Operations Leader (Large Molecule Gen Med and Vaccines)

This is a person in plant position at the SK Bio in Andong

• Location: South Korea

• Work type : Remote

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our 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. 

External Manufacturing and Supply Large Molecules Gen Med and Vaccines (EM&S LMGMV) GBU enabling end to end ownership and accountability to GBUs, with enhanced focus on operations and service. EM&S LMGMV Operations department is the operational unit responsible for ensuring on-time and in-full delivery of products from CMOs (Contract Manufacturing Organizations) and External Partners (MAMPs: Market Access Manufacturing Partnerships). The team is also responsible for contractual compliance of the business and operational aspects with respect to CMOs and External Partners management and ensures all EM&S related functional aspects of Tech Transfers and commercialization into new CMOs are effective. EM&S LMGMV Operations team interacts with functional units within EM&S LMGM V Quality and Supply team, EMPT, Sanofi sites, and other organizations within Sanofi network (e.g., MSAT, procurement, supply chain, finance, affiliates…) to ensure compliance with internal (Quality, HSES, Finances…) and regulatory requirements, and to disposition intermediate (e.g., API, drug substance) and finished products with minimal risk to quality or product supply.

Within the framework of partnership contracts with MAMPS (Market Access Manufacturing Partnerships) or Contract Manufacturing Organizations (CMOs), the External Manufacturing Operations Leader has the following missions within the scope:

Coordinate and monitor the operational execution of subcontracting activites with Sanofi external partners (CMOs) and local affiliates (MAMPs)

The position is accountable for leading the execution including local oversight (as PIP) and management of activities in support of products manufacturing operations at the assigned CMO or MAMPs, taking responsibility for delivery against the plans and in respect with the contracts. The candidate is the primary Sanofi interface for all communications with site manufacturing activities (virtual plant manager) and is expected to manage operations and communicate effectively to create value in meeting Sanofi’s business objectives.

The position may support all project management initiatives at the supplier site including tracking KPIs, manufacturing technical transfers, new product launch, compliance initiatives and continuous improvement projects. It includes management of transversal topics and projects within the External Manufacturing organization as well. The candidate will routinely manage and contribute to projects requiring close collaboration with Technical Development, Regulatory Affairs, Legal, Quality, Finance, Logistics, Planning and Business Operations, MSAT.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Control of the partners relationship and monitor the execution of contracts and manufacturing plans.

• Manage the implementation of new flows and optimize them

  Co-write the new specifications (PTS) in project mode under the leadership of Tech transfer team and manage the changes for the specifications in routine mode.

• Ensure that the CMOs and MAMPs carry out the productions according to the Specifications and contracts in place.

  Ensure that production capacity is aligned to requirements and contract obligations.

• Manage the production/release flow of subcontractors to meet customer commitments (deadlines/quantities/quality)

• Follow plan made by global Supply Chain for Vaccines or EM&S LMGMV supply for LMGM products.

• Act as PIP in our CMO facility and oversight operations

• Guarantee the proper execution of production plans between External Partners and Sanofi on Partners sites (repacking-depacking are not concerned), within a short-term horizon of 0-6 months, for on-time, in-full delivery of product from partner to customers.

  Follow production indicators.

• Coordinate deviations and Change controls (timing and release impact, creation of internal quality event if necessary…) in collaboration with EM&S LMGMV quality, Sanofi site/entity QP and quality team of the affiliate when applicable.

• Coordinate all industrial flows between partners and Sanofi sites:

  Lead the execution follow-up in accordance with the planned commitments for all areas supporting external partners (QA, QC, Supply, Logistics, Operations, MSAT, affiliates…) ensuring cross functional representation and participation.

• Manage purchase orders from procure to payment for Vaccines CMOs in ERP (managed by affiliate and site supply for MAMPs and EM&S LMGMV supply for LMGM products)

• Escalate key risks and issues to senior management, EMPT and risk manager.

  Monitor partner performance (KPIs) against production goals, identify and resolve gaps, and ensure standard governance model is implemented to track performance.

• Participate in quality audits and inspections in collaboration with EM&S LMGMV Quality

• Participate in investigations related to customer complaints/CAPA and audits.

• Projects with External Partner:

• Contribute to Binding Offers and project definition if requested by the EMPT.

• Contribute to project as project team member. (launches...)

• Improvement : lead actions in order to increase performances (TTM, VTM, yields, Quality, compliance, HSES, Finances)

​Additional Responsibilities

• Ensure reporting to internal and external clients through follow-up meetings.

• Key member of the Industrial Product Teams managed by EMPT.

• Key member of the periodic Business Review

• Contribute to projects / topics.

• Lead Lessons learned sessions with partners

About You

Leadership Qualifications

Take the lead in grey zones, do not wait for others to take it

• Customer focused and solution minded

• Courageous: promotes innovative solutions that stretch the normal operating levels

• Assertiveness: acts rather than waiting to be told what to do and demonstrates influence within the site and wider Sanofi network

• Cooperation in intercultural environments: comes to work with an open mind, ensuring we maintain a customer focus for the benefits of the company.

• Builds trust among employees: knows how to develop teamwork and foster a culture built on shared objectives.

• Accountability: takes accountability for one’s actions and those of the EM&S LMGMV entity.

• Empowers the teams to work beyond siloes, embrace strong communication and aligned purpose.

Sanofi's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Sanofi's leaders understand patient and customer needs and build relationships as required to meet goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

Basic Qualifications

• Bachelor's degree in a scientific or business-related discipline

• 5+ years in the pharmaceutical / biologics industry

• 3+ years manufacturing of DP/DS or MSAT support -

• Basics and/or CPIM certification is a plus -

• Strong communication skills with demonstrated ability to engage, motivate and evolve in matrixed teams

Preferred Qualifications

Leadership and aptitude for cross-functional management in a multicultural industrial environment

• Ability to manage projects and track changes within highly matrixed teams.

• Good understanding of organizations

• Control of Quality tools and processes (CCR, anomalies)

• Strength, reliability, and methods

• Sense of urgency, flexibility

• Experience working in a cGMP environment,

• Experience with public speaking and presenting complex information to a wide audience,

• Experience in contract management,

  Ability to synthetize complex topics, problem solve and drive for results,

• Commitment to continuous improvement including experience implementing OpEx principles such as LEAN or Six Sigma,

• Good knowledge of pharmaceutical production processes

Languages:

• South Korean(Native), English (fluent)

Special Working Conditions

• Role may require up to 50 % of the time as Person In Plant in a CMO located close to Andong (South Korea)

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.​​

  Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.​​

  Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.​​

  Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.​