Priya Ganesh
Program Compliance Manager at Novartis, CISA | CISM | PMI- PMP & ACP
- Role
- Program Quality Manager, Novartis Pharmaceuticals at Infosys
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Priya Ganesh
Quality Professional with experience in multiple domains, including Life Sciences & HealthCare, Finance, Marketing, Logistics and Supply Chain Management domains. Primarily focusing on Program / Project Quality Management, Computer System Validation, Software Quality Assurance, Quality Management Systems and Project Management. Provided Life Sciences consulting services by combining strategic consulting and project based services in the areas of Governance, Risk and Compliance, Information Security, IT Quality Systems frameworks, Computer Validation Services (CSV) in accordance with FDA and GDPR regulations, in both GxP and non-GxP environments, Process Improvement and Project Management to premier pharmaceutical, medical device and logistics companies.Skills to analyze and identify opportunities. Ability to research, analyze and translate complex business and technical information to stakeholders, SMEs and developers at all levels of the organization. Expertise in Defining, Gathering, Documenting and managing requirements to identify business needs.Experience in managing global customer delivery, account growth & team development. An accomplished project and people manager with extensive experience in project management, requirements definition, software testing and quality assurance in a variety of industries. Partnered with process consultants in developing a strategic approach to tailor agile methodology for pharmaceutical regulations. Adept at managing people, projects, accounts, customer and quality consultations; support contract negotiations and vendor on/off shore management. In addition to managing teams of varying size across all SDLC phases, track record of developing and maintaining positive relationships with individuals at all levels within and outside the organization. Skills: Program, Project and People Management for large implementations, Computer Systems Validation, SDLC, GxP, GAMP 5, IT Security, Change & Release management, Regulatory compliance including maturity assessments, audit inspection and readiness, CAPA Certifications & Knowledge base:Certified Information Security Manager, ISACA Project Management Professional Certification (PMP), PMIAgile Certified Practitioner (ACP), PMIComputer System Validation, GetReskilled Pharmaceutical Courses Certified Scrum Master (CSM), Scrum AllianceCertified Scrum Product Owner (CSPO), Scrum Institute Certified Agile Coach, Scrum InstituteSAFe Certification, Scaled Agile Inc.
Experience
Program Quality Manager, Novartis Pharmaceuticals
Jun 2019 — Present · NJ, US
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