John Moran Email & Phone Number

Ireland

Enabling the Legal and Compliance functions to realize their business objectives and drive results through the vector of technology.Key Focus Areas:• Informing Legal and Compliance leaders about emerging technologies and tailored solutions to meet their needs.• Partnering with senior stakeholders to craft and execute strategic technology roadmaps in line with business objectives• Advocating for stakeholder needs as well as ensuring compliance with security, privacy, and governance standards.• Improving customer satisfaction through optimized service delivery and continuous improvement.• Championing implementation methodologies for efficient project execution.• Overseeing financials, finding cost-saving opportunities without compromising quality.Focused on Delivering:• Building innovative solutions as Product Owner for Legal & Compliance platforms.• Creating a high-performing team culture with a focus on professional growth and collaboration.• Ensuring audit-readiness and governance alignment across all initiatives.

Dublin 4, County Dublin, Ireland

Scope: End-to-end IT partnering and delivery for autologous cell & gene therapies (CGT), plus maturing our operating model via an agile transformation in a highly regulated, cross-functional, multi-technology team. Covers the management of all project/program, enhancement and IT operations for CGT (prerequisite for Productization).Accountability for:• Business strategy and IT roadmap development across commercial, development, techops, QA and others for CGT• IT delivery covering all demand (project/program/enhancement/operations) across a suite of systems (SAP, Salesforce & others) employed in CGT• Development of the IT operating model, roles, responsibilities and a clear transformation roadmap• Working in partnership with compliance teams to revise the Computerized System Validation (CSV) approach to function on an end-to-end basis across systems in a highly regulated environment (GxP/SOX/DP)• Making the case for the transition to agile and securing buy-in from senior management (first step in shifting mindsets)• Hiring of key roles, with an emphasis on finding the right people, with the right experience and mindset• Bringing people from different organisations together, to work as a single performing team, regardless of reporting lines• Working across internal teams, often without managerial authority, to identify & address potential resistance or concerns, persuade people of the benefits, & ensure team success during delivery and transformation initiatives• Coaching the team to boost their knowledge and confidence, and prioritisation of their workload accordingly during the transition• Ensuring the meeting cadences, processes & tools were in place and applied in practice

Dublin 4, County Dublin, Ireland

Scope: Enable the order management & "vein to vein" CAR-T orchestration process via a suite of IT systems, which were key productivity enablers for business growth. Examples of its features included:• An intuitive user-friendly interface for healthcare providers, simplifying interactions with the company at key stages of the process (order management, apheresis & infusion) • End-to-end visibility and control of the supply chain for both clinical trial & commercial therapies• End-to-end Chain of Identity (CoI) / Chain of Custody (CoC)• Improved logistics via real-time updates & flexible label printing for shipment management• Monitoring capabilities for vein-to-vein cycle time and inventory levels• Ability to support a significantly scaled-up manufacturing presence & an expanding number of international marketsAccountabilities included:• Leading IT for the program, in partnership with the Business program lead• Establishing governance, steering committees & key program meeting cadences• Audit management, front & back office (3 week duration)• Senior stakeholder management including reporting and communications • Setting goals, timelines, & budgets• Coaching team members for their own & the Program's overall success• Identifying & mitigating/resolving project risks & issues, documenting decisions• Developing & implementing methodologies, tools & processes for consistent implementations• Oversight & management of all projects within program portfolio, ensuring consistency with the overall program strategy & goals • Ensuring projects within program portfolio delivered on time, within budget & to the satisfaction of stakeholders• Robust change management process adherence• Timely financial management, including cost and revenue forecasting, budgeting, & tracking• Resource management in line with Program portfolio & scope• Continuous evaluation & improvement in processes and practices• Vendor & service management

Dublin, Ireland

Accountable for the implementation of a suite of systems which was the foundation for a significant organizational change to successfully establish a cross divisional service for HR, employing SAP HRM (ERP) as the central transaction system.

Dublin, Ireland

Responsible for implementing an EFPIA (European Federation of Pharmaceutical Industries and Associations) reporting solution, in multiple sites throughout Europe. Scope includes regulation/laws which have transposed EFPIA into local law / regulations, and involved the identification and remediation of impacted business processes, as well as the implementation of a single global reporting tool.

New Jersey, Usa

Responsible for ensuring that information assets are properly managed and protected. This includes establishing policies and procedures for managing and protecting information, as well as designing and implementing systems and processes for capturing, organising, and storing information. The role also involved ensuring that information is used in compliance with regulatory requirements and internal standards, as well as providing direction for the management of information from its creation to disposal. A critical role in supporting the company's goals and objectives, and helping to ensure the availability, usability, integrity, and security of information assets.

Basel Area, Switzerland

Responsible to ensure that IT projects, programs and operations met the needs and expectations of the organization and regulatory bodies. Ensured establishment of standards and processes for measuring and evaluating the quality of IT delivery, as well as identifying and addressing any deficiencies or issues. The ultimate goal was to have IT systems and processes which were reliable, efficient, and effective- Establishing quality standards (SOPs) and metrics- Conducting quality assessments and audits to measure and evaluate the quality of IT delivery / processes- Identifying and addressing any issues or deficiencies in IT qualityImplementing improvement initiatives to improve IT quality- Communicating and coordinating with stakeholders to ensure that quality expectations are understood and met.