Krishnaveni Gottam
Senior Director, Qa Compliance @Genetix Biotherapeutics
Signup · Get unlimited contacts
WORK HISTORY
Senior Director, Qa Compliance @Genetix Biotherapeutics
Somerville, MA, US
EDUCATION
City College of San Francisco
Stem Cell Research Technology
Harvard Business School Executive Education
Certificate of Management Excellence, Business Administration and Management, General
Acharya Nagarjuna University
BS, Biology(genetics,Chemistry & Botany
Andhra University
MS, Biotechnology
University of California, Davis - Graduate School of Management
Master of Business Administration - MBA
Yale School of Management
Certification, Women leadership
SKILLS
ABOUT KRISHNAVENI GOTTAM
Over 20 years of experience in Quality ( ATMP, biologics and small molecule (both Development and Commercial areas)In-depth knowledge of QA principles, concepts, industry practices, and standardsKnowledge of GLPs and GMP regulations or equivalent 10 years of staff management experience in quality organizationProven success in leading teams and collaborating across functional teamsManaged Quality Management Reports (QMR) including key clinical and commercial QA metricsExtensive experience with quality systems (Deviation, CAPA, change control, product complaint/adverse Events)Participated in identifying and implemented process and system improvements utilizing Kaizen, Six Sigma, and DMAIC methodology in quality organizationKnowledge of Risk Management tools (e.g. FMEA, FISH bone)QA management of site manufacturing operations and direct working experience with strategic CMOs globally as Quality Functional Site LeadAnnual Quality Product Review (APQR) and Continuous Process Verification (CPV) data review and approval experienceCommercial product and CMC lead experienceReviewed and approved specifications, test methods and SOPsCoordinated inspection readiness activities and managed/participated in audits and regulatory inspectionsKnowledgeable & direct working experience reviewing and approving computer system validation, GMP manufacturing and analytical instrument related qualification activitiesStrong analytical skills and experience in performing rigorous quantitative analysis using (HPLC, Mass spec, CE-SDS, and CZE), ELISA & potency/plate assays), wet chemistry (pH, Spec Scans, moisture) & SDS-PAGE & IEF gels Leadership skillsTeam building, cross-functional collaboration, organizational communications, and presentations Managed all aspects of people related stuffOperational Excellence (OE)- managed projects as a lead using OE tools like PBL, 5S, PDCA, RCA, Kaizen and 8 wastesTechnologies: Oracle EBS, Veeva Vault, Labware LIMS, SAP, Empower, TrackWise and Global Product Complaint System (GPCS), EDMS, D2 - Documentum Library, ECMMS Maximo, Integrated Quality system (IQS), Electronic Lab Notebook (ELN)MS (Word, Excel, PowerPoint), basic python for Data Analytics, basic understanding of Artificial Intelligence & machine learning
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.