Senior Global Process Owner - Risk-Based Quality Management

Biopharma Careers; Hyderabad; Hybrid; INR 4,500,000 - 6,500,000; Full time

Job summary

Novartis is seeking a Senior Global Process Owner to design and manage end-to-end clinical development processes in a hybrid, India-based role. The candidate will drive process strategy, ensure regulatory alignment, and lead cross-functional initiatives for simplification and automation across global lines.

Responsibilities include oversight of SOPs and process documentation, monitoring performance, and mentoring teams to implement risk-based quality management throughout the clinical trial

Qualifications

• University degree in Life Science or related field.
• Extensive knowledge of end-to-end processes within clinical development or related domains.
• Strong understanding of risk-based quality management and regulatory expectations.

Responsibilities

• Own the end-to-end process design, delivery, and continuous improvement across designated processes.
• Lead cross-functional process improvement and change-management initiatives.
• Ensure governance, documentation oversight, and risk management for process-related activities.

Skills

End-to-end process ownership

Quality management

Process improvement

Cross-functional collaboration

Regulatory compliance

Education

University degree in Life Science or related field

Job description

Full time, Hybrid, #LI-Hybrid

Join a team that is redefining how Novartis delivers high‑quality medicines by integrating end‑to‑end trial process excellence with proactive, risk‑based quality management, powering smarter decisions, stronger data integrity, and faster impact for patients worldwideAs Senior Global Process Owner (Sr. GPO) you will have significant impact and accountability for designing and managing an end‑to‑end business process that is compliant with regulatory requirements and is fulfilling business needs across the end‑to‑end clinical trial process in Novartis drug Development.The role drives adoption by working collaboratively with Global Line Functions, within a complex matrix, ensuring that processes meet both high design standards, regulatory compliance, and high levels of practicality. You will be an advocate for simplification and process automation.

Major accountabilities:

1. End‑to‑End Process Ownership & Strategy
   • Accountable for the overall design, delivery, maintenance, and continuous improvement of the designated process(es).
   • Lead long‑term process strategy, ensuring alignment with regulatory expectations and business needs.
   • Anticipate internal/external changes and assess their impact on processes and supporting systems.
2. Cross‑Functional Collaboration & Process Improvement
   • Lead and support cross‑functional process improvement and change‑management initiatives.
   • Drive simplification, automation, and standardization across functions.
   • Ensure transformed processes can be executed globally by responsible line functions.
3. Governance, Documentation Oversight & Compliance
   • Ensure oversight and lifecycle management of controlled documents (SOPs, WPs, manuals) for the process.
   • Ensure coherence and harmonization across procedural documents within the process.
   • Oversee process‑related risks and ensure appropriate mitigation strategies.
   • Monitor performance trends, conduct root cause analysis/FMEAs when needed, and ensure appropriate risk management.

Minimum Requirements:

EducationMinimum: University degree in Life Science, quantitative science or business. Desirable qualifications in shared services, outsourcing, global sourcing. project management/Coaching, 6-Sigma, Lean education/training, Master of Business Administration or equivalentWork Experience: Extensive knowledge of end‑to‑end processes within clinical development, including supporting systems, regulations, and awareness of business changes.Risk-based Quality Management process design and/or implementation essential10+ years Clinical Development or Clinical Operations experience, with a strong understanding of the clinical trial lifecycle.Ability to anticipate and assess the impact of external and internal changes on the end‑to‑end process, supporting systems (and vice-versa), and associated training requirements.Experience in effective process improvement.Strategic thinker with the ability to contribute to long‑term process improvements and operational planning.Experience with process simplification and optimization, including improvements to quality documentation.Demonstrated ability to collaborate effectively across functions, supporting performance improvements within the end‑to‑end clinical development value chain.

Commitment To Diversity and Inclusion

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

Accessibility and accommodation

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

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards