Job Description

Summary Lead and manage a team within the global TRD QA Compliance organization, responsible for driving compliance activities and projects across TRD, and providing compliance-related services from a centralized location to all TRD sites with GMP capabilities (testing and/or manufacturing).
Supports local compliance teams at TRD sites in accordance with their needs and the strategy and objectives of the global TRD QA and TRD QA Compliance organization and drives aligned compliance strategies across sites.
Develop strategies for compliance-related projects, processes and tools in alignment with relevant stakeholders from TRD, TRD QA, and other compliance units within Novartis.

Key Responsibilities

• Lead and manage the team, budget and resources to meet defined objectives. Ensure timely and proactive communication of any issues or challenges to next-level manager. Develop team members ensuring their readiness to drive and support compliance activities in alignment with the TRD QA strategy and objectives.
• Active member of TRD QA Compliance Network, presenting compliance topics, assisting local compliance teams with issues resolutions, simplifying processes and ensuring excellence in the services provided. Ensure and facilitate active involvement of other team members.
• Represent TRD QA in global and/or cross-functional compliance related projects, networks and initiatives, ensuring appropriate oversight with strong quality guidance, scientific and technical expertise.
• Develop or contribute to the strategy of compliance-related projects, processes and tools, including contingency planning and risk assessment as required. Ensure that the strategy implemented aligns with TRD QA strategy and objectives, and complies with cGMP guidelines and internal procedures.
• Ensure timely communication of the overall project strategy, key issues, and other critical topics to management, project lead, and relevant team members. Proactively manage compliance-related interactions between TRD QA and other stakeholders within TRD and/or Novartis (e.g., RDQ, Global Quality). Closely collaborate with TRD business compliance roles (e.g., GMP officers) and drive alignment across sites.
• Coach, guide and mentor stakeholders outside TRD QA Compliance organization. Key compliance accountabilities include support to documentation management, quality monitoring, and involvement in projects and life-cycle activities related to compliance IT tools.

Minimum Requirements:

• M.Pharm/ Masters in science
• 10-14 years of experience

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
Skills Desired Agility, Auditing, Audit Management, Business Partnering, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Stakeholder Management, Technological Expertise, Vendor Management