Sr Business Solutions Manager-CMC-Manufacturing SystemsApply Now Job ID 1602776 Date posted12/05/2016 LocationCambridge, Massachusetts, United States; Boston, Massachusetts, United States; Deerfield, Illinois, United States;
- Leads the analysis of complex business problems and elicits and documents business requirements. Understands the customer’s business and manages relationships with key customers.
- Sets scope and business priority-setting for change initiatives of large size and complexity, and leads system implementations.
- Influences stakeholders to prioritize requirements and to ensure the total solution delivered to the customer meets/exceeds expectations.
- Proactively identifies technology solutions to meet business objectives, taking into account the implications of change on the organization and all stakeholders.
- Uses knowledge of business operations to identify and investigate operational needs and problems, and opportunities, and leads the implementation of improvements within area of responsibility.
- Sole contributor or leader of a small team to deliver IT solutions that allow the business to reach its strategic objectives and are implemented in a cost efficient and high quality manner
- Has authority and responsibility for a significant area of work, including technical, financial and quality aspects. When appropriate, leads organizational objectives and delegates responsibilities. Is accountable for actions and decisions taken by self and subordinates.
- Directs business process design and requirements analysis on large/complex project. Ensures documentation according to Takeda QMS standards, policies and procedures.
- Leads requirements gathering, prioritization and negotiation with business management on a BU level.
- Is a subject matter expert in the business area of expertise, understands one or more BU organizations and related technical landscapes
- Responsible for delivery of large-scale changes and delivery of IT projects.
- Makes decisions which impact the work of employing organizations, achievement of organizational objectives and financial performance.
- Influences policy formation on the contribution of own specialism to business objectives. Influences a significant part of own organization. Develops influential relationships with internal and external customers/suppliers/partners at senior management level, including industry leaders.
- Recommends strategy, validating and justifying business needs, conducting feasibility studies, producing high-level and detailed business models, preparing business cases, overseeing development and implementation of solutions,
- Actively shares emerging industry standards/trends with customers and peers within area of responsibility
- Assures projects and project team members follow all company and departmental policies, procedures and standards
- Ensures delivered solutions are compliant with associated federal regulations (SOX, OFCCP, labor laws, GMP, GxP, GCP, etc)
- Proactively identifies and assists in prioritizing opportunities to streamline business and/or system processes.
- Monitors and champions the implementations of the current IT portfolio and changes within the VO leadership and IT
- Leads the prioritization of the current work streams and changes to the IT portfolio by the VO leadership and coordination of portfolio activities.
- Leads the impact analyses of VO Leadership changes in the IT portfolio, assessing and addressing the impact to and influence the VO and IT Leadership and communicating the impact to the rest of the IT organization.
- Leads a small matrix team of analysts and engineers experienced in assessing and determinate the impact for the IT organization and discuss this with IT management
- Acts as a change agent based on the scientific IT portfolio and the business strategy to the IT organization in order to align the IT Architecture.
- Engages with scientific leaders and ensure that IT has a role within major strategic change initiatives by executing a business aligned IT strategy that will contribute to the success of Takeda’s vaccine efforts, building trust by proper execution of IT project and services and identify new technologies and determine achievability to serve VO
- Develop, communicate, and execute on a business-aligned IT strategy that will contribute to the success of Takeda’s vaccine efforts;
- Work with other Takeda IT that support business functional areas such as CMC to leverage existing Takeda IT portfolio in support of VO, or to identify new technologies to serve VO;
- Develop business cases, secure approval & resources required to pursue the development of new capabilities & investments, manage the development of requirement specifications related to these, and charter & guide the efforts of matrixed project teams in their implementation;
- Direct the proper execution of IT projects and services; ensure that the appropriate delivery-side & architecture resources are available to support & sustain projects; negotiate priorities and support requirements with shared services & infrastructure IT
- Facilitate and follow through on the resolution of tactical IT issues on behalf of VO by directing these to the appropri
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors Degree or high school degree and 12 years of work experience in any business related field.
- 8 + years of relevant experience
- Extensive experience supporting functional processes and technical design.
- Extensive experience implementing applications.
- Excellent user knowledge of relevant systems solutions.
- Excellent oral and written communications skills, business acumen with problem solving and analytical skills
- Ability to write and speak the English language
- 10+ years' working experience as an IT professional with at least 5 years of experience in an IT Leadership role.
- 5+ years’ experience in IT Program Management and/or business analysis
- 5+ years' experience in a scientific or biotech/pharma environment and familiar with drug development processes for large-molecule biologics, preferably vaccines. Specific domains include bioprocess & formulations development, cell culture & analytical development, CMC, and Manufacturing;
- Experience with GxP and related regulations governing development and manufacturing of biological products, particularly vaccines, as well as IT SDLC and software validation processes;
- Experience with information systems for lab assay data, process & methods development, data query & analysis, lab automation & LIMS, and inventory;
- Keenly developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships;
- Demonstrated successful management of IT projects, including scope, financial, and schedule goals;
- Experience working with solutions delivery teams such as corporate IT infrastructure/architecture, applications development & integration, and support;
- Ability to operate effectively in a matrix environment; team player.
- Pharmaceutical industry and/or drug development business experience
- Experience with SAP, specifically direct materials inventory and manufacturing forecasting, as well as with SAP integrations with other applications such as LIMS.
- Experience with IT integration of external partners such as Contract Manufacturing Organizations.
- Familiarity with lab instrumentation, such as mass spec, chromatography, bioreactors, and process control systems.
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