Site Risk Officer

Sanofi•Swiftwater, PA

11d•Onsite

About The Position

The Site Risk Officer (SRO) is a critical role within the Site Portfolio Management Team, responsible for leading the standardized and comprehensive risk management process at the site level. This position plays a pivotal role in identifying, assessing, and mitigating potential threats and vulnerabilities that may impact site operations and organization. In addition, the SRO serves as the primary point of accountability for the business continuity program and cyber resilience program, ensuring alignment with Sanofi's global standards, regulatory requirements, and patient safety objectives. The SRO partners cross-functionally with Manufacturing & Supply (M&S), Quality, Digital, Supply Chain, Finance, and global risk management teams to identify, assess, mitigate, and monitor risks that could impact site operations, product quality, regulatory compliance, and business continuity. This role requires a strategic thinker with strong leadership capabilities, deep knowledge of pharmaceutical/biotech operations, and the ability to drive complex, multi-stakeholder programs from inception through execution. 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. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Requirements

Bachelor's Degree required.
10+ years relevant experience in manufacturing environment.
Experience in business continuity/project /Risk management desired.

Responsibilities

Manage the Site Risk Profile: Own and maintain the site-level risk register, ensuring risks are identified, assessed, prioritized, and tracked in alignment with Sanofi's global risk management framework and governance standards.
Lead periodic risk assessments across all site functions (Manufacturing, Quality, Supply Chain, Digital, HSE, etc.) to identify emerging risks and evaluate the effectiveness of existing controls.
Provide a relevant site risk picture under a standard process, regardless of risk nature (industrial, quality, HSE, material, etc.).
Develop and present risk reports, dashboards, and heat maps to the Site Leadership Team (SLT) and global stakeholders on a defined cadence (monthly, quarterly, annually), highlighting critical risks, trends, and mitigation progress.
Facilitate risk workshops and cross-functional risk reviews to ensure comprehensive risk identification and shared accountability across departments.
Lead site risk governances and foster interactions with product line management.
Ensure risk mitigation action plans are assigned to appropriate owners, tracked to completion, and escalated when necessary.
Maintain alignment with global risk governance bodies, contributing to global risk reporting and benchmarking across Sanofi manufacturing sites.
Support internal and external audits and health authority inspections related to risk management practices, ensuring inspection readiness at all times.
Lead the Site Business Continuity Program: Design, implement, and continuously improve the site Business Continuity Program in accordance with Sanofi global standards, ISO 22301, and applicable regulatory requirements.
Conduct Business Impact Analyses (BIA) across all critical site functions to identify maximum tolerable downtime, recovery time objectives (RTOs), and recovery point objectives (RPOs) for key processes and systems.
Develop, maintain, and test Business Continuity Plans (BCPs) and Crisis Management Plans for critical site operations, ensuring plans are actionable, current, and accessible.
Lead and coordinate tabletop exercises, simulations, and full-scale drills at a minimum annual frequency; document lessons learned and drive continuous improvement of plans.
Establish and maintain a site Crisis Management Team (CMT), defining roles, responsibilities, escalation protocols, and communication trees.
Coordinate with global business continuity teams to ensure site plans align with global continuity strategies and reporting requirements.
Track and report on BCP program maturity metrics, exercise outcomes, and plan update status to site leadership and global stakeholders.
Ensure all critical vital records are identified, protected, and recoverable in alignment with site and global vital records management requirements.
Lead the Site Cyber Resilience Program: Serve as the site lead for the Sanofi global Cyber Resilience program, coordinating local implementation of global cyber resilience requirements, standards, and initiatives.