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

Sanofi; Location (WV); Remote; USD 100,000 - 140,000; Full time

Job summary

A global healthcare company is seeking an External Manufacturing Operations Leader to oversee production processes and ensure compliance with contracts. The ideal candidate will have over 5 years of experience in the pharmaceutical industry and strong project management skills. This role includes significant interaction with external partners and requires effective communication and leadership within a complex operational environment.

Benefits

Health and wellbeing benefits

Gender-neutral parental leave

Opportunities for career advancement

Qualifications

• 5+ years in the pharmaceutical/biologics industry.
• 3+ years in manufacturing of DP/DS or MSAT support.
• Experience in a cGMP environment.

Responsibilities

• Coordinate and monitor operational execution with external partners.
• Ensure production capacity aligns with contract obligations.
• Manage production/release flow of subcontractors.

Skills

Leadership

Communication skills

Project management

Customer focus

Problem solving

Education

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

Job description

Overview

This is a person in plant position at 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 enables end to end ownership and accountability to GBUs, with enhanced focus on operations and service. EM&S LMGMV Operations ensures on-time and in-full delivery of products from CMOs and External Partners (MAMPs), contracts compliance, tech transfers, and commercialization into new CMOs. The team collaborates with Quality, Supply, MSAT, procurement, and other Sanofi units to ensure compliance with internal and regulatory requirements and to disposition intermediates and finished products with minimal risk to quality or supply.

Within partnership contracts with MAMPS or CMOs, the External Manufacturing Operations Leader has the following missions within scope:

Coordinate and monitor the operational execution of subcontracting activities with Sanofi external partners (CMOs) and local affiliates (MAMPs). The role leads execution—including local oversight (as PIP) and management of activities in support of product manufacturing operations at the assigned CMO or MAMPs—with responsibility for delivery against plans and in accordance with 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 launches, compliance initiatives and continuous improvement projects. It includes management of transversal topics and projects within the External Manufacturing organization. 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 teams explore new technologies to protect people and promote healthy communities.

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 new specifications (PTS) in project mode under the leadership of Tech transfer team and manage changes for specifications in routine mode.
• Ensure that the CMOs and MAMPs carry out productions according to the Specifications and contracts in place.
• Ensure 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 oversee operations.
• Guarantee proper execution of production plans between External Partners and Sanofi on Partners sites, within a short-term horizon (0-6 months), for on-time, in-full delivery of product.
• Follow production indicators.
• Coordinate deviations and change controls in collaboration with EM&S LMGMV Quality and site quality teams.
• Coordinate industrial flows between partners and Sanofi sites and lead execution follow-up across QA, QC, Supply, Logistics, Operations, MSAT, and affiliates.
• Manage purchase orders from procure to payment for Vaccines CMOs in ERP (managed by affiliate and site supply for MAMPs and LMGMV).
• Escalate key risks and issues to senior management; monitor partner performance (KPIs) against production goals and ensure governance models are in place.
• Participate in quality audits, inspections, investigations related to customer complaints/CAPA and audits.
• Projects with External Partner: contribute to binding offers and project definition; participate as project team member; lead improvement actions to increase performance (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 beyond normal operating levels.
• Assertiveness: acts and influences within the site and wider network.
• Cooperation in intercultural environments; maintain customer focus for the company’s benefit.
• Builds trust among employees and fosters teamwork with shared objectives.
• Accountability for actions of the EM&S LMGMV entity.
• Empowers teams to work beyond siloes with strong communication and aligned purpose.

Sanofi's leaders operate effectively in evolving environments, provide direction, and seek best practices to improve operations.

They understand patient and customer needs and build relationships to meet goals while improving operations and maintaining high standards.

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.
• CPIM certification is a plus.
• Strong communication skills with ability to engage and motivate in matrixed teams.

Preferred Qualifications

• Leadership and cross-functional management in a multicultural industrial environment.
• Project management and change tracking in highly matrixed teams.
• Understanding of organizations and Quality tools/processes (CCR, anomalies).
• Reliability, strong methods, sense of urgency, flexibility.
• Experience in a cGMP environment and public speaking; ability to present complex information.
• Experience in contract management and problem solving with results focus.
• Commitment to continuous improvement (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 near Andong (South Korea).

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Opportunities to grow your talent and advance your career, locally or internationally.
• Rewards package that recognizes your contribution and amplifies your impact.
• Health and wellbeing benefits including healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.