Director Clinical Process Excellence

Sandoz India; Telangana; Hybrid; INR 2,800,000 - 4,200,000; Full time

Job summary

Sandoz India is seeking a senior clinical operations leader to establish robust governance across development and operations, drive QMS improvements, and ensure regulatory alignment. The role oversees documentation, training, audits, and cross-functional collaboration with Legal, Medical Affairs, and Data Privacy to enable compliant, efficient clinical programs.

With 13+ years in pharma and a global, multi-country perspective, you will lead teams, energize stakeholders, and deliver process

Qualifications

• 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.

Responsibilities

• 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.

Skills

Leadership

Communication

Stakeholder management

Organizational skills

Change management

Negotiation

Strategic thinking

Global/cross-cultural teamwork

Independent problem solving

Job description

• 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

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!