Major accountabilities:

Team Leadership:

• Lead a team to ensure alignment with organizational goals and business priorities related to Release Management, and support the strategic vision for Platform Operations from a Capability level; foster a culture of excellence and continuous improvement  
• Act as a Change Lead and implement change management strategies to ensure smooth adoption of technology initiatives, at the Capability level

Roadmap Development:

• Responsible for the oversight, the planning and the continuous deployment of releases across Technology Projects/Products, and their alignment as part of an integrated roadmap, from a Capability level
• Coordinate with relevant affected Products/Capabilities/Platforms Teams to manage dependencies across multiple releases and ensure alignment of data, system configurations and user experience. Ensure that any interdependencies are identified, tracked, and resolved in a timely manner to prevent delays or conflicts, from a Capability level

Stakeholder Engagement:

• Represent the Capability in digital governance boards and leadership meetings across the organization
• Represent the Capability 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 within the Capability and the Platform, and with relevant stakeholders to achieve business priorities.
• Oversee vendors at the capability level, across product(s), in collaboration with IT and the External Partnerships Teams

Quality and Compliance:

• Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned Capability/Product(s), aligned with the NVS Quality Manual
• Ensure adherence to Security and Compliance policies and procedures within the scope of the Capability and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections).

Release Management:

• Ensure the Release Management Capability is fit for purpose (incl. related processes such as SOPs, WIs, etc.) and achieves the desired business value and impact
• Oversee the end-to-end release lifecycle, from planning through to deployment and post-deployment support. Ensure that each stage of the release process is executed efficiently and adheres to established timelines and quality standards
• Identify, assess, and manage risks associated with release activities. Develop contingency plans to address potential issues and ensure minimal disruption to business operations
• Establish key performance indicators (KPIs) to measure the effectiveness of the release management process. Regularly track and report on these metrics to identify areas for improvement and demonstrate the value of the capability team.

Project and Program Support:

• Provide support/resources for key projects and programs impacting the Capability and/or underlying Product(s), ensuring timely delivery of high-quality milestones in alignment with business requirements

Demand Management:

• Effectively manage demand(s) for technology services and operational support related to release management activities, arising from various functions withing Regulatory Affairs
• Monitor service delivery performance and backlog

Industry Trends:

. Stay updated with industry trends and emerging practices to drive agility, innovation, speed, efficiency, effectiveness, and continuous improvement within the Capability

Key performance indicators:

• Achieve key Regulatory Affairs business objectives and stakeholder milestones by leading the Capability, ensuring timely and on budget delivery of the Capability roadmap
• Deploy Releases supported by the Capability in a timely and successful manner (e.g. through the measure of number of defects found post-release and the percentage of successful deployments, gathering user feedback on new releases, etc.)
• Improve user experience for solutions and services for product(s) underlying the capability
• Enable RA operational execution through dedicated management of the Capability and underlying Products and Services, maximizing the value provided by our systems:
• Improvement of the landscape performance and user satisfaction
• Adoption and harmonization of high performing technology solutions leading to simplification of the landscape and reduction in number of systems, delivered on time and in budget
• No critical findings in audits and inspections related to the release management process for RA Products

Minimum Requirements:

“Bachelor’s degree, master’s; Advanced degree in life science, pharmaceutical, technology, or data science preferred”.

Work Experience and Skills:

• 8+ years of relevant industry experience
• Strong understanding and direct relevant experience with the Release Management landscape of pharmaceutical regulatory affairs
• Advance knowledge of drug development process as well as international drug registration and approval, of Regulatory Business processes and information management
• Hands-on experience in technology process requirements
• Extensive experience leading meetings, driving change and cross-functional teams
• Excellent problem-solving skills and in seeking clarity in ambiguous situations
• Leadership in risk assessment, strategic thinking, prioritization, and global awareness
• Excellent business writing, communication and effective presentation skills
• Technically savvy
• Broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena, and strong knowledge of relevant regulatory requirements
• Strong experience in release management activities in the context of major projects/releases

Languages :

• Fluency in English as Business language.