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 RD, 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.
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 RD, 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
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 deliveryStrong analytical and problem-solving skillsExcellent communication and interpersonal skillsAbility to work effectively in a team environment and build strong relationships with stakeholdersDemonstrated ability to lead and motivate team membersExperience with data analysis and visualization tools is a plusPreferred:
· 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
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 deliveryStrong analytical and problem-solving skillsExcellent communication and interpersonal skillsAbility to work effectively in a team environment and build strong relationships with stakeholdersDemonstrated ability to lead and motivate team membersExperience with data analysis and visualization tools is a plusPreferred:
· 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