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Head, Global IT Validation

10.00 to 14.00 Years   Bangalore   07 Dec, 2022
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

    JOB RESPONSIBILITIESPrimary responsibilities will include:Opperations managementWorking with the AD V&C to do resource forecasting and management of validation resources for the portfolio of projectsAct as the escelation point for clarity and manageral discression for the day to day opperations of the Validiation COE staffTraining coordinationEnsure resources in COE are trained and onboarded effectivelyProgram level leadershipProvide guidance for implementaiton teams on complex mulit-project programsCompliance SMEAct as compliance SME to provide guidance on related compliance issues and coordinate with privacy, security and SoXWork GPO for CSV on any escelations of interpretationProject level contribuationAuthoring of Validation core deliverables and review of SDLC documents for the project team on projects they are assigned toQUALIFICATIONS & EXPERIENCEThe ideal candidate will bring a combination of strategic planning, strong relationship management experience, continuous improvement mindset, strong change management and communication skills, strong portfolio management skills and influencing skills together. In addition, this person should also possess:10 + years experience in SDLC/Computer Systems Validation with at least 5 years leading teams performing SDLC or IT Quality/Compliance activities, preferably Pharmaceutical and/or Medical Device industries.Experienced applying IT control methodologies and processes such as SDLC (Waterfall and Agile SCRUM), Change Management including GAMP5 and ITIL within a regulated environment.Experienced applying Risk Analysis to system assuranceProven track-record of building and leading strong teams, overseeing Suppliers and developing talent.Knowledge of GxPs regulations for medical device products, international requirements, and quality system development and management.Document Management experience using ServiceNow Managed Documents, SAP Solution Manager and/or SAP DMS/ECM a plus.Experience with HPAML a plusAbility to communicate complex business / technical challenges in a simplified mannerMust be a leader who can influence stakeholders in written and oral communicationsHighly collaborative work style which includes working effectively globally and across all organizational levelsExperience working in a highly matrixed global organization and in overcoming ambiguityLeading by example, mentoring, and motivating others all around youProven experience of managing / briefing other teams or third partiesProven analytical, evaluative, and problem-solving abilitiesExcellent judgment and decision-makingStrong humility, listening, creativity, and negotiation skillsEducationBachelors degree in IT, business, finance, or a related field is required.Masters degree highly desirable.ASQ Quality/Regulatory and ITIL certification a plus.PMP, Six Sigma, Lean trained and /or certified a plus.,

Keyskills :
ITILSDLCPMP

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