Job Description

Summary Oversee all aspects of quality management and ensure the highest level of compliance across our projects

Major accountabilities:

• Oversee & support all areas of quality management for GxP/non GxP Systems.
• Drive the validation process, including validation planning, testing (IQ/OQ/PQ), and validation reporting.
• Support Authoring, reviewing, and approving of CSV deliverables for accuracy, consistency, clarity and completeness.
• Ensuring all the validation SOP/Work Procedures are followed during the application development.
• Coordinate with project managers and teams to ensure the alignment of project outputs with quality standards.
• Evaluate data and QM processes to identify improvements to enhance efficiency and accuracy.
• Manage change control processes for tool updates and deployments while driving continuous improvements in validation and quality workflows.
• Support in audits and inspections to ensure adherence to compliance regulations and industry standards. Create and maintain documentation of processes and validation activities and provide training to teams on quality standards and procedures.
• Oversee root cause analysis, corrective actions, and preventive actions to address quality issues. Ensure all systems and software used meet industry regulations and data integrity rule

Minimum Requirements:

• Minimum of 10 years' experience in Quality Management, ideally within the Pharma or any regulated industry.
• Proven experience in managing GxP/non GxP projects from requirement definition to retirement.
• Working experience in all lifecycle stages of IT system(including System retirement) would be preferred.
• Ability to drive innovative validation strategies for business initiatives
• Knowledge of IT systems and software used within the Pharma industry.
• Exceptional leadership skills with the ability to drive a team towards meeting quality standards.
• High attention to detail with the ability to identify potential risks or issues.
• Solid interpersonal skills, including the ability to build and maintain effective working relationships.
• Ability to influence and drive collaboration across all levels of the organization.
• Bachelor's degree in IT, Pharmacy or related field.

• Why Novartis:

Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Skills Desired Algorithms, Computer Programming, Computer Science, Computer Vision, Data Science, People Management, R&D (Research And Development), Solution Design, Waterfall Model