IT Lead TPO NextGen Digital Manufacturing Essential Job Duties and Responsibilities + Product Strategy and Vision: Define and communicate the product vision, roadmap, and key performance indicators (KPIs) for IT solutions within the pharmaceutical business, ensuring alignment with company objectives and industry regulations. + Stakeholder Collaboration: Work with business stakeholders such as R&D, production, marketing, quality assurance, and regulatory teams to gather requirements, understand pain points, and deliver solutions that meet business and compliance needs. + Product Development: Lead the product lifecycle, from ideation and requirements gathering through to development, testing, deployment, and maintenance, ensuring products are delivered on time, within budget, and meet quality standards. + Regulatory Compliance: Ensure all IT products meet necessary compliance standards and regulatory requirements specific to the pharmaceutical industry (e.g., FDA 21 CFR Part 11, GxP, ISO). + Agile Methodology: Utilize agile methodologies to prioritize and manage product backlogs, sprint planning, and execution to ensure a continuous delivery of product enhancements and solutions. + Risk Management: Proactively identify risks related to product development, implementation, and usage, and collaborate with relevant teams to mitigate those risks. + Data Management: Oversee the implementation of systems and solutions that handle sensitive data, ensuring appropriate data security measures, data integrity, and privacy compliance (e.g., GDPR, HIPAA). + Continuous Improvement: Identify opportunities to enhance product functionality, usability, and performance, and work on iterating solutions based on feedback from users and stakeholders. + Budget Management: Manage budgets for product development and ensure cost-effective resource allocation. Key Competencies: + Strong understanding of pharmaceutical industry regulations, including GxP, FDA, and ISO standards. + Experience with Agile frameworks (Scrum, Kanban) and tools such as JIRA, Trello, or Confluence. + Excellent communication skills, with the ability to collaborate with cross-functional teams and explain technical concepts to non-technical stakeholders. + Ability to translate complex business needs into technical requirements and solutions. + Strong analytical, problem-solving, and decision-making skills. + Knowledge of pharmaceutical manufacturing processes and supply chain management is a plus. + Experience with IT systems related to clinical trials, manufacturing execution systems (MES), enterprise resource planning (ERP), or laboratory information management systems (LIMS) is advantageous. + Proven experience as a Product Owner, Business Analyst, or Project Manager in the IT space, ideally within the pharmaceutical, life sciences, or healthcare industry. **Qualifications** Qualifications Minimum Education: + Bachelor’s degree in computer science, business administration, industrial engineering, or another discipline relevant for the healthcare industry or equivalent experience. Experience and Skills: Required: + 6+ years of experience in technical program/project management, preferably in a Supply Chain environment. + Experience in technology integrations and program delivery + Strong analytical and problem-solving skills + Excellent communication and interpersonal skills + Ability to work effectively in a team environment and build strong relationships with stakeholders + Demonstrated ability to lead and motivate team members + Experience with data analysis and visualization tools is a plus Preferred: + Experience in IT project management and product lifecycle management in a regulated environment. + Familiarity with digital transformation projects, cloud-based solutions, and data analytics platforms. + Working knowledge of multiple technical disciplines and concepts (SAP, MES, Historian (OSIsoft), Databases, GenAI, ML, Digital-Twin, eLIMS, Labelling solutions, Infrastructure such as WAN/LAN, Hosting, and Storage solutions, MS Windows, Desktop computing hardware and software, and peripherals (e.g. handheld scanner) + Familiar with standard concepts, practices, and procedures associated with frameworks (Agile, ITIL) + Knowledge of software development and testing methodologies (SDLC, CSV) + Basic understanding of business drivers/processes and the ability to relate priorities to associated technology investments. + Ability to create context around key business drivers and strategic plan and present ideas in business-friendly and user-friendly language Other: Language requirements – English, and Dutch is desirable