Mgr of Clinical Quality Assurance
General Responsibilities
• Responsible for maintaining quality and ensuring that studies, documents, and submissions to regulatory agencies meet required industry and agency specified standards (Good Clinical Practices);
• Understand the phases, processes and techniques used to execute a Quality Assurance Plan;
• Provide training and mentoring to CQA staff and Clinical Operations on subjects such as Good Clinical Practices (GCP), Good Pharmacovigilance (GPvP), EU Directives, Health Canada or other non-USA Regulations and Guidelines;
• Assist in applying principals of 21 CFR Part 11 to clinical systems;
• Lead the development of effective SOPs, Checklists, Templates, Quality Assurance Reports and training materials;
• Assist in development, management, and execution of audit programs for clinical studies and functional areas of oversight;
• Provide internal consulting to project teams as needed;
• Collaborate with outside business partners and parent company as necessary;
• Interact with Clinical Research Organizations (CRO’s) as necessary;
• Assure adherence to Company Policies, SOPs and Quality Systems;
• Perform and oversee Quality Audits of vendors, partners and collaborators to ensure compliance with regulations, agreements and SOPs;
• Perform Quality Review of documents, and regulatory submissions;
• Effectively and accurately document audit findings by generating an audit report, or other Quality Assurance summaries and obtain responses in a timely fashion;
• Follow-up on all open audits until closure;
• Evaluate audit responses for compliance with applicable guidelines, regulations, and Standard Operating Procedures/Policies;
• Discuss …cont.
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