Description
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