Site Operations Director

Sanofi - Trenton, NJ

Full-time - Senior

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Site Operations Director at Sanofi Group is responsible for overseeing the operations of contract manufacturing organizations (CMOs) to ensure timely and complete delivery of healthcare products. This role involves close collaboration with external partners and requires frequent presence at the CMO site in Vacaville, CA. The director will manage operational and financial aspects of production, address issues, and ensure compliance with quality standards.

Responsibilities

• Work in partnership with the External Manufacturing Site team and Specialty Care Functional Leadership.
• Ensure on-time and in-full delivery of products for CMOs/External Suppliers by being present at the contract manufacturing site during key manufacturing activities.
• Understand the products from an operational and financial perspective, providing routine technical support and timely information to stakeholders.
• Build collaborative business relationships with external partners to ensure delivery timelines are met.
• Serve as the first level of escalation for problems encountered with CMO activities and production.
• Participate in CMO driven Joint Steering Committee meetings.
• Escalate issues to appropriate forums as needed.
• Understand contract guidelines and their impact on product/departmental P&L of production variations.
• Implement Life Cycle management projects.
• Adhere to the Risk Management Program to identify, evaluate, document, and communicate risks impacting quality and compliance.
• Ensure compliance through participation in quality governance forums.
• Review and provide technical input on critical deviations and approve Category 3 Change Requests.
• Interface with external regulatory authorities as required.
• Work with External Site Team Leads and Functions heads for standardization of processes and procedures.

Requirements

• Bachelor's degree with scientific background or equivalent and 8+ years of experience, or a Master's degree with scientific background or equivalent and 6+ years of experience.
• Experience in large molecule pharmaceutical manufacturing operations.
• Knowledge/understanding of supply chain logistics.
• Knowledgeable in support quality investigations.
• Experience with Lean/Six Sigma methodology.
• Experience with operational excellence and continuous improvement initiatives.
• Strong communication and collaboration skills.
• Good functional knowledge of industrial business processes.
• Good exposure to cross sites & cross Global Business Units networking is a plus.

Nice-to-haves

• Knowledgeable in biotech/pharmaceutical industry technologies (drug substance, drug product, and finished goods; devices preferred).
• Knowledgeable in E2E product & industrial strategy, performance management, project management.
• Basic understanding of data management and digital products.
• Strong analytical skills.