Deployment Lead - Paperless Solutions

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Job Title: Deployment Lead - Paperless Solutions

Location: Zurich, Switzerland

As Deployment Lead for the paperless implementation, you will be to supporting the global rollout of an IT solution for paperless forms and logbooks within the GxP environment. You will help drive the implementation of complex electronic logbooks, forms, and streamlined user experiences together with the ICC (Innovation Capability Center) and site citizen developers. You will ensure that the implementation of paperless forms follows GxP regulations, such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).

• Partner across departments and international manufacturing sites to deliver on time and within budget. Develop, track and measure key performance indicators mid to long term.
• Within the program management, monitor deployment progress, identifying and addressing any deviations or roadblocks to ensure project milestones are met.
• Investigate and implement solutions during the roll-out and the ongoing support to change paper-based processes into paperless and set up and support activities required for that change.
• Support implementation of paperless solution for GxP forms and logbooks across the entire manufacturing portfolio and network together with the ICC and sites, whilst considering resource allocation and risks.
• Coordinate with the IT team, Subject Matter Experts, ICC, user community, demand and release management, local deployment to configure and customize the solution according to requirements and regulatory standards.
• Ensure computer system validation and the required tasks like testing, validation efforts, problem resolution, change control processes and implementing periodic review to ensure system functionality and compliance with GxP guidelines.
• Coordinate required interfaces, integrating necessary data fields, and ensuring compliance with relevant regulations and standards. (eg EDB)
• Collaborate with our quality teams and vendors to implement appropriate validation processes, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure the reliability and accuracy of the electronic forms.
• Document deployment processes, procedures and best practices to facilitate knowledge transfer and future upgrades and enhancements.
• Project management skills with experience leading complex IT deployment projects
• Subject matter expertise for GxP tools
• Important partners are DD&T partners, business SMEs (Subject Matter Experts) from manufacturing and operational excellence teams, ICC and Quality partners.
• Proficiency in change management principles and methodologies to lead user adoption and minimize resistance
• Understand Software Development Life Cycle, quality validation processes and application processes.
• Participate in the validation of computerized system, ensure deployment of patches and Version upgrades.

• Bachelor's degree or equivalent in Computer Science or a related field with experience in systems.
• Experience with software development, business analysis, or process optimization.
• Experience with validation processes, including writing deliverables for validated systems.
• Experience with business system and computer system validation in system testing, validation, problem resolution, and training.
• Provide training and support to local citizen developers, addressing inquiries and resolving issues throughout the deployment process.
• Proficiency in tools such as JIRA, Confluence, and electronic form builders.
• Willing to implement solutions in a low code environment.
• Familiarity with Agile methodologies and user-centered design principles.
• Experience in Manufacturing Process and Pharmaceuticals industrial would be ideal.
• Subject matter expert with GxP tools and Understand and follow SDLC (Software Development Life Cycle), quality validation processes and application processes.
• Project management skills with experience leading complex IT deployment projects.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.