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  • Business System Owner - GxP

    Sanofi Group (Swiftwater, PA)



    Apply Now

    **Job Title:** Business System Owner

    **Location:** Swiftwater, PA

     

    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.

     

    The Local Business System Owner (BSO) is responsible for Swiftwater site implementation, lifecycle, and compliance with global Smart Factory solutions that support Manufacturing & Supply operations. This role reports to the Swiftwater Smart Factory Head and is crucial in driving digital innovation and modernization at the site level while maintaining alignment with global strategies, processes, and core models.

     

    We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

     

    **This is a hybrid role - 4 days a week onsite - required. **

    Main Responsibilities:

    Governance & Compliance

    + Ensure alignment of site procedures and practices with Sanofi Global Quality Documents.

    + Act as gatekeeper for local system adherence, including audit trail review, user access control, and local application of business procedures.

    + Represent the site in their area of expertise and interact with Quality, Digital, and Business functions (site and global).

    System Ownership

    + Maintain the validated state of the Sanofi Smart Factory System at the site level.

    + Ensure the system remains fit-for-purpose and aligned with evolving core models and business needs.

    System Use & Support

    + Ensure system usage meets business needs and supports operational efficiency.

    + Provide training and support to end users, promoting standardization and best practices.

    + Lead the network of key users and provide Level 2 and Level 3 support.

    Innovation & Roadmap

    + Initiate local use cases and communicate site-specific pain points to the global team.

    + Drive business activities related to solution implementation initiatives

    + Business Value Projects

    + Major and Minor releases

    + Legacy System Decommissioning

    + Represent the site in design authority and participate in roadmap discussions to ensure alignment with global direction.

    Collaboration Focus

    + Collaborate closely with the site Smart Factory Head, global BSO, and other stakeholders to ensure local needs are represented and aligned with global strategy.

    Quality Management

    + Manage deviations, CAPAs, change control, documentation, training, audit trail reviews, access management, and business continuity.

    + Investigate and resolve incidents related to the system.

    + Participate in local qualification phases and contribute to audits and inspections.

    Resource & Budget Management

    + Define and allocate resources and budgets for system evolution projects and maintenance activities.

    + Plan system-related activities and provide visibility on priorities.

    Documentation, Processes & Support

    + Review and approve local documentation related to system configuration, design, and operations.

    + Support users in adopting digital solutions and ensure proper documentation and training are in place.

    Change Management

    + Support users in adopting digital solutions and develop a change plan for the business transformation supporting the change

    + Develop and execute communication plans to site and global stakeholders

    + Drive continuous improvement for Smart Factory solutions through collaboration with Sanofi Manufacturing Standards & Area Process areas

     

    About You

    Required Qualifications

    Education:

    + Bachelor’s Degree - Engineering, Life or Data Sciences or related discipline - preferred.

    + A combination of education and experience will be considered.

    Experience:

    + 5+ years of experience in the Pharmaceutical Industry, Computerized System implementation or Project Management experience - preferred.

    + GxP and Data Integrity knowledge - required.

    Preferred Qualifications:

    + **Work Experience:** Experience with successfully Leading Project teams, Experience with Continuous Improvement and Service Level Management (SLA) related to Incident Management. Experience with Risk Assessment.

    + **Technical skill:** Experience with standard industry systems including but not limited to: SAP, SIEMENS, Veeva, & Power BI

    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-SP

    \#LI-SP

    \#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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

     

    _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.

     

    _North America Applicants Only_

    The salary range for this position is:

    $108,750.00 - $157,083.33

     

    All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

     

    Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

     

    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 visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

     

    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.

     

    All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)

     


    Apply Now



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