Director Clinical Process Excellence

Posted 2 Days Ago
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Sandoz, CA, USA
In-Office
Expert/Leader
Biotech • Pharmaceutical
The Role
Lead design, governance, and continuous improvement of clinical process frameworks and quality systems (QMS) across clinical development. Manage SOPs, templates, eTMF/SharePoint documentation, regulatory intelligence, training, audits/CAPA, and cross-functional collaboration to ensure compliant, standardized, and efficient clinical operations.
Summary Generated by Built In

Job Description Summary

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!
Accountable to lead the design, governance, and continuous optimization of clinical process frameworks and quality systems for clinical development, ensuring efficient management of SOPs, templates, regulatory intelligence, training, audits, and operational processes; drive standardization, compliance, and cross-functional collaboration to support high-quality clinical execution and sustainable operational excellence.

Job Description

Major accountabilities: 

  • Process Governance & Standardization: Establish and oversee robust clinical process governance frameworks, including management of process forums, SOP systems, and standardized templates to ensure consistency and efficiency across clinical operations. 

  • Quality System Management: Lead the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring alignment with regulatory requirements and organizational standards.

  • Documentation & Knowledge Management: Ensure effective management of clinical documentation, including SOP master lists, eTMF templates, SharePoint systems, and archival processes, to support compliance, traceability, and accessibility.

  • Regulatory Intelligence & Compliance Oversight: Drive regulatory intelligence gathering and assessment, translating insights into actionable process improvements and ensuring ongoing compliance with evolving regulations.

  • Training & Capability Building: Oversee clinical training strategy and delivery (including GCP and process training), ensuring workforce capability, compliance, and continuous skill development.

  • Audit, Inspection & Continuous Improvement: Lead/ support internal audits (as per assignment), self-inspections, and quality investigations (including CAPA coordination), driving remediation actions and embedding a culture of continuous improvement and inspection readiness.

  • Cross-functional Collaboration & Operational Support: Partner with Legal, Data Privacy, Medical Affairs, and other stakeholders to ensure integrated process execution, while supporting key administrative and operational activities such as onboarding, organizational governance, and system transitions.

Minimum Requirements: 
  Work Experience:

  • 13+ years pharmaceutical industry clinical experience in Development and Clinical Operations

  • Excellent leadership, communication (written/verbal), stakeholders’ management and collaboration skills

  • Excellent organizational skills, with the ability to prioritize/work effectively in a changing environment

  • Extensive experience in conducting a wide range of study types and the end-to-end clinical process

  • Experience in people management and development across countries with the ability to energize others around purpose/impact

  • Strong interpersonal, problem-solving, change management and negotiation skills

  • Displays strategic thinking, an innovative mindset and a solutions-oriented approach

  • Experience in a global environment with the ability to lead cross functional, multi-cultural teams

  • Ability to work independently and create innovative solutions with little direction

 

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! 

Join us!

Skills Desired

Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management

Skills Required

  • 13+ years pharmaceutical industry clinical experience in Development and Clinical Operations
  • Extensive experience conducting a wide range of study types and end-to-end clinical processes
  • Experience in people management and development across countries, leading cross-functional, multi-cultural teams
  • Excellent leadership, written and verbal communication, stakeholder management and collaboration skills
  • Excellent organizational skills with ability to prioritize and work effectively in a changing environment
  • Strong interpersonal, problem-solving, change management and negotiation skills
  • Strategic thinking, innovative mindset and solutions-oriented approach
  • Experience in a global environment with ability to lead cross-functional, multi-cultural teams
  • Ability to work independently and create innovative solutions with little direction
  • Experience with Quality Management Systems, SOP governance, audit readiness and CAPA coordination
  • Clinical Research
  • Clinical Trials
  • Program Management
  • Regulatory Compliance
  • Resource Management (Organizational) and Risk Management

Sandoz Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sandoz and has not been reviewed or approved by Sandoz.

  • Healthcare Strength Health, dental, vision, and prescription coverage are consistently described as core components across U.S. roles and materials. Feedback suggests the medical offering is broad and a standard pillar of the package.
  • Retirement Support A 401(k) plan with a company match described as generous is commonly included for U.S. roles. This savings support is positioned alongside other primary benefits as part of total rewards.
  • Equity Value & Accessibility Equity eligibility is noted for many positions and a global all‑employee share program is being introduced from 2026. These elements add upside beyond base salary and annual bonus.

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The Company
HQ: Basel
17,135 Employees

What We Do

Sandoz is the global leader in generic and biosimilar medicines. ​ ​Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.​ We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.

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