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Sandoz

Bio Global SBS / OPEX Lead (d/f/m)

Posted 3 Days Ago
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Remote
Hiring Remotely in Sandoz, CA, USA
Senior level
Remote
Hiring Remotely in Sandoz, CA, USA
Senior level
Lead design and deployment of an enterprise Operational Excellence/Sandoz Business System across biosimilars development and manufacturing. Drive GMP-compatible improvement initiatives (Lean, Six Sigma, DMAIC) to improve safety, quality, delivery, cost and sustainability; establish governance, track benefits, embed capabilities, partner with Quality, and leverage digital manufacturing analytics and MES/EBR systems to sustain continuous improvement across global sites.
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Job Description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! 

The role is responsible for designing, deploying, and sustaining an enterprise-wide Operational Excellence and SBS (Sandoz Business System) methodology across the Biosimilars development, manufacturing and supply network. The role drives measurable improvements in safety, quality, delivery, cost, and sustainability, ensuring initiatives are fully aligned with GMP/GxP expectations and business priorities. The role acts as a coach, transformation leader, and system architect, embedding a culture of continuous improvement and capabilities that endure beyond individual projects. 

 

Your Key Responsibilities: 

Your responsibilities include, but not limited to: 

 

  • Define and continuously improve the Operational Excellence Management / SBS strategy and roadmap in full alignment with business priorities, network targets and regulatory expectations. 

  • Develop and deploy the OPEX / SBS model, establish governance processes (steering, prioritization, benefits validation and escalation paths), and ensure consistent deployment across the Biosimilars platform network. 

  • Drive the roll-out and consistent application of OPEX / SBS across Biosimilar Development, production sites and platform functions. 

  • Build and manage a portfolio of GMP-compatible improvement initiatives with clear charters, baselines and financial/operational benefit tracking, ensuring benefits are realized and sustained through control plans, standardization and capability building. 

  • Act as a change champion and lead cross-platform improvement programs focused on first-time-right performance, deviation reduction, batch release cycle time reduction, OEE and throughput increases, yield improvement, scrap reduction, changeover reduction (SMED), warehouse and planning optimization, and labor productivity improvement. 

  • Partner with Quality to embed OPEX / SBS into deviation management, CAPA and change control effectiveness, quality risk management (ICH Q9), data integrity, inspection readiness, audit sustainability and compliance requirements. 

  • Develop and drive the OPEX / SBS capability-building strategy across the Biosimilars platform through Lean, Six Sigma and DMAIC methodologies; train and certify teams in structured problem solving, root cause analysis, CAPA effectiveness, deviation investigation quality and statistical tools; and foster a sustainable continuous improvement culture. 

  • Build a network of OPEX / SBS leaders and champions, promote community-of-practice sharing, collaborate with Digital/IT and Engineering to leverage analytics, MES, EBR, historian insights and dashboards, and engage leadership through change management, transparent progress reporting and performance/risk updates for global leadership forums. 

 

What you’ll bring to the role: 

Essential Requirements: 

 

  • Bachelor’s degree in Engineering, Pharmacy, Chemistry, Life Sciences, Industrial Engineering or equivalent. 

  • 8–12+ years of experience in pharmaceutical manufacturing, biotechnology and/or medical devices within GMP/GxP-regulated environments. 

  • Fluent in English (written and spoken). 

  • Expertise in structured problem solving (A3, DMAIC), root cause analysis and Lean Six Sigma Black Belt (or equivalent CI certification). 

  • Strong knowledge of Lean systems and tools, including Daily Management, VSM, 5S, SMED, Kanban, Standard Work and Visual Management. 

  • Familiarity with ICH guidelines, Quality Risk Management principles, and strong commitment to data integrity, documentation and compliance standards. 

  • Experience with digital manufacturing technologies and analytics, including SPC, MES/EBR and performance dashboards. 

  • Proven track record leading cross-functional and cross-site transformation initiatives, delivering measurable operational improvements in global matrix organizations and influencing senior stakeholders. 

  • Excellent communication, facilitation, coaching and training skills, with the ability to build high-performing teams, lead without authority, drive stakeholder engagement, and combine strategic thinking with hands-on execution of continuous improvement initiatives. 

 

Why Sandoz? 

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health. 

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.  

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!  

Join us, help us make healthcare fairer and faster. 

Commitment to Diversity & Inclusion:  

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.  

Accessibility and accommodation  

Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to [email protected]  and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 

#Sandoz 

 

 

 

 

Skills Desired

Building Construction, Business Networking, Continual Improvement Process, Diversity & Inclusion, Efficiency, Finance, Leadership, Manufacturing Production, Operational Excellence, Operations, Order Fulfillment, Product Distribution, Productivity, Public Speaking, Purchase, Web Applications

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