Job Title: Site Operations Director

Location: Bridgewater, NJ OR US Remote

MUST BE LOCATED NEAR AND ABLE TO TRAVEL TO THE CMO LOCATED IN VACAVILLE, CA

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. Your job, as Site Operations Director within our Site Operations Team will be to [summary of opportunity].

Reporting to External Manufacturing and Supply Large Molecule Site Operations Lead and ensuring on time & in full delivery by in person presence at the CMO

• External Manufacturing Site team, Specialty Care Functional Leadership
  
• Ensures on time & in full delivery of products for CMOs/External Suppliers (CMO facility is located in Vacaville, CA) within site management unit by being present at the contract manufacturing site during key manufacturing activities.
  
• Accountable to understand the products as it is implemented at the CMOs from an operational & financial perspective, able to provide routine technical support, and provide timely information to all stakeholders.
  
• Build collaborative business relationships with external partners as key partner to ensure on time & in full delivery by frequent presence at the CMO site.
  
• Serve as the first level of escalation to the External Manufacturing Product Teams (EMPT) as it relates to problems encountered with CMO activities & production.
  
• Actively participates in CMO driven Joint Steering Committee (JSC) meetings.
  
• Escalates issues to appropriate forums, as needed.
  
• Accountable to understand the contract guidelines and the impact to the product/departmental P&L of production variations.
  
• Responsible for implementing Life Cycle management projects.
  
• Responsible for the adherence to the Risk Management Program to identify, evaluate, document, and communicate risks potentially impacting quality and compliance; involves a multi-disciplinary team to define remediation plans to mitigate risks impacting products and GxP operations.
  
• Ensure Compliance through active participation at all applicable quality governance forums (including Quality Management Reviews and Periodic Business Reviews).
  
• Accountable for reviewing and providing technical of critical deviations.
  
• Accountable for on time Quality System related records, also reviews and approve all Category 3 Change Requests.
  
• Interface with external regulatory authorities as required.
  
• Works with External Site Team Leads (EST) and Functions heads for standardization of processes and procedures required to manage CMOs and related work within External Site Team.
  

• Bachelor's degree with scientific background or equivalent and 8+ years of experience
  
• 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
  
• Lean/Six sigma methodology
  
• Experience with operational excellence and continuous improvement initiatives
  
• Strong communication and collaboration skills
  
• Good functional knowledge on industrial business processes
  
• Good exposure to cross sites & cross Global Business Units (GBUs) networking is a plus.
  

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

• Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation, while remaining pragmatic and focus on priorities. Able to shape a vision. Able to lead & animate networks, teams, experts - Strong communication skills.
  
• Results orientation: Demonstrated ability to drive initiatives from concept to execution.
  
• High level of autonomy. Executes, comfortable with ambiguity,and adapts with agility. Takes calculated risks and anticipates potential issues.
  
• Relationship & Influence: able to manage ambiguity and partners without solid reporting line.
  
• Inspires trust through empathy and authenticity. Empowers and recognizes others to create powerful relationships and networks.
  
• Stretched ambition and act. Encourages the teams to stretch and do things differently & creates space for the teams to act.
  
• Commit to Patients and full product quality. Makes sure the teams understand how to act for patients and customers.
  
• Approaches the role with humility and thinks Sanofi first.
  

• Fluent English
  

• 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 andwellness programs and at least 14 weeks' gender-neutral parental leave.