Mala Sharma

About Mala Sharma

BOARD & GOVERNANCE (INDEPENDENT DIRECTOR)Independent Director and GxP Quality Advisor supporting Audit, Risk, and Quality Committees with oversight of regulatory compliance, enterprise risk management (ERM), and governance effectiveness in pharmaceutical and life sciences organisations.Brings a global governance perspective, informed by professional travel to 75+ countries and experience as a Responsible Sourcing Auditor, enabling informed oversight of labour standards, human rights, and country-specific labour law risks across complex supply chains.Provides independent challenge and escalation across GCP, GDP, and Pharmacovigilance (PV), helping boards understand where quality, patient safety, and compliance risks translate into enterprise and reputational risk.Additionally qualified and experienced in environmental auditing, contributing to board-level oversight of ESG, environmental compliance, and sustainable operations, alongside data privacy obligations under India’s DPDP Act. CONSULTING & GxP QUALITY ADVISORYSenior GxP Quality Consultant supporting pharmaceutical and biotech organisations with GCP, GDP, and Pharmacovigilance (PV) audits, inspection readiness, and remediation strategy across the product lifecycle. Regulatory and quality leadership experience supporting stem cell and gene therapy (ATMP) programmes from development through inspection readiness and commercial scale-up.Brings deep experience in Quality Risk Management (QRM), including risk identification, prioritisation, and mitigation aligned to ICH Q9 principles, supporting leadership teams in focusing resources on areas of highest regulatory and patient safety risk.Leads risk-based audit planning and execution, covering internal, supplier, CRO, and distributor audits—ensuring audit programmes are proportionate, inspection-ready, and aligned to enterprise risk and governance priorities.Recognised for critical thinking, regulator-facing judgement, calm execution during inspections, and the ability to translate audit observations into practical, risk-based actions and CAPA governance.Engages in independent audits, fractional quality advisory, and targeted consulting engagements, particularly in complex or inspection-sensitive environments.

Experience

1. Guest Faculty

   Cliniminds India

   Oct 2025 — Present

Education

• Bangalore University

  Bachelor of Science - BS, Microbiology, General

• Cranfield University, ICRI

  Master of Science (M.Sc.), Clinical Research

  2006 — 2007

• QMI

  iSO 14000, Lead auditor in environmental processes

• Bangalore University

  Bachelor of Science - BS, Microbiology

  1990 — 1994

• Bangalore University

  Master's degree, Clinical/Medical Laboratory Science/Research and Allied Professions

• Benchmark India

  Green belt in six sigma, Six sigma

  2012

• RQA UK

  Practical pharmacovigilance auditing course, Pharmacovigilance

  2016

• QMI

  Lead auditor in Quality Management system and Environmental management system

  2000

Skills

• Glp
• Quality Assurance
• Life Sciences
• Calibration
• Haccp
• Pharmaceutics
• Regulatory Affairs
• Analytical Chemistry
• Capa
• Iso 9000
• Clinical Trials
• Certfied Lead Auditor - Ems ,Qms
• Quality System
• Ich-Gcp
• Pharmacovigilance
• Gmp
• Oshas
• Good Clinical Practice (Gcp)
• Six Sigma
• Project Management
• Standard Operating Procedure (Sop)
• Responsible Sourcing - Supplier Audits
• Green Belt - Six Sigma
• Management
• Regulatory Requirements
• Quality Management
• Change Control
• Corporate Compliance and Ethics
• Cgmp Manufacturing
• Regulatory Submissions
• Validation
• Gcp
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Tqm