Quality Assurance Lead

Job Title: Lead, Quality Assurance & Regulatory Compliance

Primary Responsibilities

• Assure that CRO Operations remains in compliance with corporate policies and procedures and all applicable worldwide regulations & guidelines.
• Deploy, Manage & improve quality management system and create awareness across the organization.
• Plan & roll out regulatory readiness program for eventual regulatory audits.
• Ensure effective execution of the readiness program.
• Assess the effectiveness of inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. inspection readiness assessments).
• Provide consultation to operations & business enabling functions personnel on Requirements (Organization, regulatory & client) & compliance issues.
• Impart awareness session on applicable regulations (FDA, MHRA etc.).
• Lead cross-func...