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Director Quality Audits & Compliance
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- The Director of Quality Audits & Compliance is responsible to independently lead, manage, and coordinate Quality GCP and GLP regulated activities and is responsible for performance of domestic and international audits/inspections that ultimately ensure compliance to the appropriate level of Quality and regulatory standards (such as FDA, EMA, or MHRA).
- GCP, and GLP Quality Systems responsibilities include training, document management (SOPs and other controlled documents), change control, process improvement, and quality Quality systems activities will be coordinated with the Quality Systems group.
- Manage and lead audit and quality systems for GCP/GLP functions including resource planning, budgeting and forecast support.
- Must have extensive knowledge of GLP/GCP audits and compliance applicable to Global GCP and GLP regulatory requirements.
- Experience with clinical and regulated non-clinical auditStrong acumen and demonstrated ability in GLP/GCP auditing , FDA and EMEA regulations inclusive of direct experience with Pharmacovigilance and System Development Life Cycle activities.
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