Sanofi
Site Operations Director
Sanofi, Bridgewater, Massachusetts, us, 02324
Time left to apply: End Date: December 31, 2024 (30+ days left to apply)Job Requisition ID: R2766096Job Title:
Site Operations DirectorMUST BE LOCATED NEAR AND ABLE TO TRAVEL TO THE CMO LOCATED IN VACAVILLE, CAAbout 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:
Work in partnership with External Manufacturing Site team and Specialty Care Functional Leadership.Ensure 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.Understand the products as they are implemented at the CMOs from an operational & financial perspective, provide routine technical support, and provide timely information to all stakeholders.Build collaborative business relationships with external partners 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) regarding problems encountered with CMO activities & production.Participate actively in CMO driven Joint Steering Committee (JSC) meetings.Escalate issues to appropriate forums as needed.Understand the contract guidelines and the impact on the 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 potentially impacting quality and compliance; involve 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).Review and provide technical input on critical deviations.Ensure on time Quality System related records, review and approve all Category 3 Change Requests.Interface with external regulatory authorities as required.Work 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, CAExperience:
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 supporting quality investigations.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 (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.Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation while remaining pragmatic and focused on priorities.Results orientation: Demonstrated ability to drive initiatives from concept to execution.High level of autonomy; comfortable with ambiguity and adapts with agility.Relationship & Influence: able to manage ambiguity and partners without solid reporting line.Inspires trust through empathy and authenticity.Commits to Patients and full product quality.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.About Us
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us by visiting www.sanofi.com or via our movie We are Sanofi.Why Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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Site Operations DirectorMUST BE LOCATED NEAR AND ABLE TO TRAVEL TO THE CMO LOCATED IN VACAVILLE, CAAbout 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:
Work in partnership with External Manufacturing Site team and Specialty Care Functional Leadership.Ensure 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.Understand the products as they are implemented at the CMOs from an operational & financial perspective, provide routine technical support, and provide timely information to all stakeholders.Build collaborative business relationships with external partners 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) regarding problems encountered with CMO activities & production.Participate actively in CMO driven Joint Steering Committee (JSC) meetings.Escalate issues to appropriate forums as needed.Understand the contract guidelines and the impact on the 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 potentially impacting quality and compliance; involve 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).Review and provide technical input on critical deviations.Ensure on time Quality System related records, review and approve all Category 3 Change Requests.Interface with external regulatory authorities as required.Work 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, CAExperience:
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 supporting quality investigations.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 (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.Strategic thinking: analyzes current and future scenarios, disrupts the status quo with innovation while remaining pragmatic and focused on priorities.Results orientation: Demonstrated ability to drive initiatives from concept to execution.High level of autonomy; comfortable with ambiguity and adapts with agility.Relationship & Influence: able to manage ambiguity and partners without solid reporting line.Inspires trust through empathy and authenticity.Commits to Patients and full product quality.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.About Us
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us by visiting www.sanofi.com or via our movie We are Sanofi.Why Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
#J-18808-Ljbffr