Manoj Singh
Regional Head GCP/PV Quality Audit AMAC-EU-APAC-META
- Role
- Regional Head Gcp Pv Quality Audit Amac-eu-apac-meta at 诺华
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Manoj Singh
19 years of experience in Pharmacovigilance (PV) and Clinical Research (Good Clinical Practice (GCP)) domain. Lead, support and report independent GCP/PV audits according to the Novartis Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed on behalf of Global GxP Audit include internal and external targets of country organizations, external services providers, process and quality systems, laboratories, investigator site, for-cause and mock pre-approval inspections Align strategic direction with senior leaders of Novartis and help establish programs to implement. Provide GxP expert consultation to Novartis business units through risk-based system assessments. Represent the company in external interactions with Health Authorities and industry groups.
Experience
Regional Head Gcp Pv Quality Audit Amac-eu-apac-meta
Aug 2024 — Present · Mumbai, IN
Education
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master of Business Administration (M.B.A.), Pharma Management
2008 — 2011
Academy of Clinical Excellence (ACE), Bombay College of Pharmacy
PG Diploma in Clinical Research, Clinical Research Management, Regulatory Affairs, Pharmacovigilance and CDM
2005 — 2006
Maharashtra University of Health Sciences
BHMS
1999 — 2004
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.