Krista Stover

Senior Manager, Standards & Audit @The Janssen Pharmaceutical Companies Of Johnson & Johnson

Glassboro, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2023 — Present

Senior Manager, Standards & Audit @The Janssen Pharmaceutical Companies Of Johnson & Johnson

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Responsible for assuring compliance to all regulatory requirements through the management and maintenance of robust applications and systems for Audit and Internal/External Standards Deployment processes to Janssen. Supports the process owner and has a clear understanding of the relevant business rules, functional area(s), managed data, data lifecycles and downstream implications to other systems, processes, and applications.* Lead efforts for the for the monitoring, standardization, and improvement of processes for Audit and Internal/ External Standards Management* Develop strategies for Janssen audit applications in collaboration with global business partnersAct as an Applications Lead and SME for IT projects to facilitate gathering of user stories and implementation of solutions in alignment with Pharma Quality Systems and IT strategies* Is responsible for applications development and integration activities as required* Facilitate/ attend forums/ meetings to understand, discuss and prioritize audit and standards system/ applications needs* Collates and reports on metrics and data for Leadership awareness and prioritization of IT application improvement projects.* Engages with Functional Process Owners to review/ analyze process-related data for the purpose of identifying areas of improvement for related applications.* Identifies gaps, compliance risks and process improvements for continued compliance and identifies potential process efficiencies and opportunities for standardization and simplification.

EDUCATION

1997 — 2001

Drew University

BA, Chemistry

2008 — 2011

Rider University

MBA

2001 — 2003

University of Delaware

M.S. Biochemistry

SKILLS

Laboratory Information Management System (Lims)Lifesciences21 Cfr Part 11Analytical ChemistryVerification and Validation (V&V)Medical DevicesCapaBiotechnologyQuality AssurancePharmaceutical IndustrySopFdaStandard Operating Procedure (Sop)ValidationTechnology TransferChromatographyGood Laboratory Practice (Glp)Change ControlQuality SystemV&VHplcGxpChemistryLimsHigh-Performance Liquid Chromatography (Hplc)GlpGmpLife Sciences

ABOUT KRISTA STOVER

Senior Manager, Standards & Audit

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Krista Stover — Senior Manager, Standards & Audit at The Janssen Pharmaceutical Companies Of Johnson & Johnson in Glassboro, NJ, US | Unifers