Platform Operations Lead

Job Description Summary

As a key member of the RA Data and Technology Function, the Director of Platform Operations will shape and execute the operational strategy, delivering business benefits through harmonization and continuous improvement. Leading a team of associates, this role ensures efficient Platform Operations for RA systems.
The Platform Operation oversees Release Management, Migration, Validation and Business Administration capabilities. These respectively support RA technology products by ensuring continuous alignment and deployment of releases; defining strategy and executing migration of data and information; ensuring access control, security management and continuous operation and availability of technology products.
The Platform Operation Lead is accountable to ensure that the overall platform strategy delivers business benefits, drives harmonization and continuous improvements. By aligning the digital strategy and initiatives with regulatory priorities, the Platform Operation Lead plays an essential role in enhancing the efficiency, consistency and agility of regulatory activities, strengthening the organization’s ability to respond effectively in a dynamic global landscape.

Job Description

Major accountabilities:

• Team Leadership:

  • Lead a diverse global team to ensure alignment with organizational goals and business priorities related to Submissions and Registration Management

  • Define and communicate the strategic vision for Submission and Registration Management capabilities, fostering a culture of excellence and continuous improvement.

  • Regularly assess team performance against established metrics and objectives. Provide feedback, recognize achievements, and address areas for improvement through coaching and development opportunities.

  • Promote a collaborative and inclusive work environment, where team members are empowered to contribute to their full potential.

• Roadmap Development:

  • Define, prioritize, and deploy an integrated platform roadmap in collaboration with RA D&T LT, relevant stakeholders, and DDIT partners, ensuring alignment with the Development and Enterprise technology strategy roadmaps.

• Stakeholder engagement:

  • Represent the platform in digital governance boards and leadership meetings across the organization

  • Represent the platform in digital networks, externally (e.g. across Industries) as needed

  • Communicate effectively to ensure understanding and support for new technology initiatives. 

  • Support continuous expansion of knowledge and foster the adoption of a digital mindset within Regulatory Affairs.

• Collaboration and Partnerships:

  • Build and maintain collaborative and productive partnerships across the Platform team and enterprise stakeholders to achieve business priorities.

  • Oversee vendors at the Platform level, in collaboration with IT and External Partnership Teams

• Quality and Compliance:

  • Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned capabilities, aligned with the NVS Quality Manual.

  • Contribute to the change management strategy to ensure smooth adoption of technology initiatives, as required

  • Ensure adherence to Security and Compliance policies and procedures within the scope of the Platform, and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections).

• Project and Program Support:

  • Provide support and resources for key projects and programs impacting the underlying capabilities to ensure timely delivery of high-quality milestones that align with business requirements. 

  • Collaborate with business, IT, and other stakeholders to develop and define project scope, objectives, and interdependencies for projects.

• Demand Management:

  • Effectively manage demands for technology services and operational support arising from various functions within Regulatory Affairs.

  • Ensure monitoring of overall service delivery performance and backlog.

• Industry Trends:

• Stay updated with industry trends and emerging practices to drive agility, speed, efficiency, and effectiveness within the team.

• Accountable for release management processes to ensure timely and coordinated delivery of software updates and system enhancements across global platforms.

• Accountable for the establishment of validation frameworks/standards for essential system platforms and applications to ensure compliance with regulatory and industry standards within the life sciences sector.

• Accountable for the establishment of migration frameworks/standards and the managing/executing of migration projects, ensuring a seamless transition and integration of new Systems, Data and Applications with minimal disruption to business.

• Accountable for the establishment of Business Administration frameworks/standards and implementation for the management of RA technology programs, focusing on efficiency and effectiveness.

Work Experience:

• 8+ years of industry experience

• Bachelor’s degree: master’s or commensurate experience. Advanced degree in life science, pharmaceutical, technology, or data science preferred

• Matrix / cross-functional leadership experience preferred

• Strong understanding and direct relevant experience with the technology landscape operations of pharmaceutical regulatory affairs

• Strong strategic problem-solving skills and ability to navigate un-charted territory without clear precedent

• Experience presenting/speaking at a senior management level with a proven track record of effectively communicating complex initiatives

• Strong global leadership skills demonstrated by a proven track record of successfully managing people, technology initiatives and/or leading groups or teams, inspiring innovative, strategic and big picture thinking.

• Demonstrated leadership in driving risk assessment and mitigation, clear strategic thinking, prioritization, maintaining awareness of global patient and business impact.

• Strong negotiation skills

• Excellent verbal and written communications

• Strong experience in technology process requirements, migration, release management, and validation/testing including audit and knowledge of regulatory requirements

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 

Commitment to Diversity & Inclusion:

We are 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 all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in any order to receive more detailed information about essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 

Skills Desired

Data Analysis, Documentation Management, Lifesciences, People Management, Proactivity, Process Improvement, Regulatory Compliance, Waterfall Model