Greetings fromiClanz
Business Analyst Development Operations andValidation
Location : Remote only from Canada canapply
Description
The Business Analyst (BA) is a selfstarterwith expertlevel Business Analysis capabilities a passion fortransforming healthcare a high level of flexibility and acommitment to delivering value to patients.
They must be aneffective negotiator leader and communicator when partnering withRoche / Genentech s global Technical Operations business unitsincluding Manufacturing Quality Supply Chain Technical Developmentand Technical Regulatory as well as with IT crossfunctionalteams.
The BA will work closely with one ormore internal Roche / Genentech business organizations and the ITdomain organizations to understand strategic drivers and tacticalneeds.
This will ensure that IT implementation teams can provideproducts that meet business needs with high business valuestability usability and scalability.
They will be assigned to theAdvanced Therapies Product Line of the Technical Operations Domain.Their focus area is the Development Operations and Validation teamof the Individualized Therapies / Cell Therapies (ITCT) Agile ReleaseTrain (ART).
The successful candidate will contribute their BAcapabilities expert knowledge of Agile release trains developmentoperations extensive experience in GxPcompliant workingenvironments and mastery of Computer System Validation (CSV)required to deliver regulated GMP IT products andcapabilities.
Responsibilities :
Analyze / document current and future business process modelshighlevel requirements (scope) and detailed functionalspecifications or agile user stories with acceptancecriteria.
Guide and support other Business Analysts andProduct Owners as they develop the detailed requirements or agileuser stories with acceptance criteria.
Lead / contribute toall acceptance testing efforts including SAT UAT dry runs and othertypes of testing.
Supporting the implementation of ITsolutions that require GxP validation.
Effectivelycommunicate with the IT development team and the extended projectteam.
Independently make BA project decisions with impactat the process organization or program level.
Tailormessaging to different target audiences and choose appropriatecommunication channels.
Act as a Lead BA and / or ProductOwner Delegate on large / global or multiportfolioinitiatives / projects.
Actively look for opportunities toimprove how business processes are executed.
Qualifications :
Bachelor s degree in engineeringinformation technology or science with 57 years of relatedexperience.
Experience with technical developmentmaterial sciences or manufacturing in a pharmaceuticalcompany.
Knowledge of solutions such as LIMS ELN QualitySystems (Veeva) but also data management solutions.
Experience in and understanding of application developmentmethodology including Agile and Waterfall approaches processmodeling and reengineering user acceptance testing organizationalchange management and largescale / global systemimplementations.
Proven leadership abilities andemotional intelligence.
Demonstrated success in handlinginitiatives of high complexity high profile and large scale / globalprograms.
Proven skills in relationship buildinginfluencing customer focus decisionmaking andproblemsolving.
Demonstrated ability to learn thebusiness in unfamiliar areas quickly and remain curious.
Excellent communication (written and oral) and presentation skills;solid business acumen; and wellhoned influencing skills areessential.
Selfmotivated and teamoriented; able to workboth autonomously and effectively as part of a geographicallydispersed team.
Comfortable working with Googlecollaboration tools JIRA and HP ALM.
StrongPreference For :
Experience with supporting theimplementation of IT solutions that require GxPvalidation.
Experience with working as a member of anagile development team proficiency with agile methodologies andconcepts such as User Stories Story Maps Personasetc
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Regards
Kevin
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