Job Description
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-functional teams to help identify potential issues and resolve current issues.
Manage compliance iss...
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-functional teams to help identify potential issues and resolve current issues.
Manage compliance iss...
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