| The Senior Manager R&D IT Product Management at Otsuka will engage with different roles and function to provide architectural overview of proposed solutions outlining components, relationships and dependencies that will serve as the primary basis of timely decision making. Collaborate and partner across lines of business and the IT groups in order to understand strategic drivers and tactical needs to ensure implementation teams can provide technically innovative solutions that meet the business needs with the necessary usability, technical stability and scalability. Other responsibilities include: - Plan and develop the Architectural Runway in support of new business Features and Capabilities.
- Produce information flows, architecture, technology roadmaps and technical implementation blueprints in close alignment with business capability roadmaps.
- Ensure solutions being developed, takes global needs into accounts, architecturally flexible to extend to related business areas and affiliates ensuring maintainability and supportability of systems and are enterprise grade. Support projects and operational activities in the Global Quality solutions portfolio.
- Develops, assigns and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CAPA.
- Experience in establishing QMS life cycle process models aligning with GxP/21 CFR Part 11/ GAMP 5 requirements.
- Ensuring GxP computerized systems operate within the framework of regulations or standards (GxP, 21 CFR Part 11 and GAMP 5) applicable company Quality Modules and requirements defined in Global and local procedures.
- Have complete domain knowledge of Pharmaceutical, Biotechnology and Life Sciences.
- Experience in providing trainings on Domain Knowledge, GxP Compliance, Testing & Deviation Management, Validation Process and Methodologies.
- Actively seeks and drives opportunities for continuous improvement of applications, during team's project work and for internal processes.
- Create and own the Solution Architecture documentation and works closely with the technical team (Technical Project Manager, Lead Developer, developers/software engineers, testers) to monitor technical development of solutions; configures the system when necessary.
- Actively participates in Architecture Community of Practice internally and/or externally (industry forums, vendors etc.)
- Ensure that Solutions are technically/ architecturally consistent, fit for purpose, meet customer requirements and comply with all relevant IT and business standards such as reuse of technologies and solutions, and simplicity and usability.
- Actively seeks and drives opportunities for continuous improvement of applications, during team's project work and for internal processes.
- Ensure support of key business processes and appropriate levels of integration / automation.
- Help bridge the gaps and hand-offs issues between requirements / functional resources, development teams, and project leadership / sponsorship.
- Provide leadership to ensure that capabilities delivered align with original business objectives, application service levels, IT strategies, and design intent.
- Synthesize and communicate complex technical and business information easily to senior management and business stakeholders.
- Develop strategy and execution plans for implementation of cutting-edge technologies and processes while managing the ongoing needs of application development and support. Work within IT and with other cross-functional groups and with vendors, to successfully identify, prioritize, and resolve issues and work on enhancements, developments, and operational improvements.
- Create and manage project plans and timelines, define project deliverables, assign project team roles and resources, identify and track issues and their resolution, and manage project scope and requirements.
- Lead requirements workshops, design, prototype, configure and document content management/QMS data solutions.
QUALIFICATIONS - BA/BS Degree is required with 7-10 years relevant experience
- Experience in Project Management and IT Development and Design
- Experience with Quality Management systems like CAPA system, Learning Management System, SOP and Document Management Systems highly preferred.
- Experience with Agile methodologies and DevOps frameworks.
- Should be experienced with cloud infrastructures and deployments.
- Experience with Analytics and BI is preferred.
- Should be willing and be able to work in a highly cross team environment and possess good communication and inter personal skills.
- Experience in working in a regulated and validated environment and experience in Pharmaceutical and Life Sciences industry would be preferred.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status. Statement Regarding Job Recruiting Fraud Scams Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website https://external-otsuka.icims.com/ . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website. |
