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
Main Responsibilities:
The Site Operations Leader will work:
in partnership
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.
About You
**MUST BE LOCATED NEAR AND ABLE TO TRAVEL TO THE CMO LOCATED IN VACAVILLE, CA**
Experience:
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.
Skills:
Technical skills
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
Leadership skills
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.
Languages:
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
