Director Quality Assurance LOC : Miami,FL
100,000 - 200,000
Job Description:
Manager Notes:Working for a pharma or device manufacturer is ok, but there are a couple of very specific things we need to see in a resume:
- Clinical experience someplace where they were involved with clinical trials
- GCP in all the acronyms they throw out this one is a must (Good Clinical Practices) aka ICH E6
- 21 CFR ideally this would appear too.
- These are the FDA regulations guiding clinical trials.
- Directs all Biorasi Quality Assurance including GCP Compliance and Audit activities; develops QA processes, plans and conducts Biorasi Internal Audits, Investigator Audits, and Vendor Audits, facilitates Sponsor
- Audits and FDA Regulatory Inspections while acting as the advocate for Biorasis position and interpretation of regulatory guidelines.
- In consultation with Branch Heads and the SVP Process and Quality, updates Biorasi SOPs and Forms; ensures GCP compliance with FDA regulations and ICH guidelines, identifies updates and improvements to Biorasi SOPs and Forms, ensures consistency and relevance of content across all SOPs, audits SOPs against the biorasis process methodology to identify areas of inconsistency, and addresses any audit findings by updating SOPs as requested.
- Directs the Biorasi Deviation Report and CAPA Report programs; provides management and summary reporting to Branch Heads,
- SVP Process and Quality and CEO at their request, and works with Branch Heads and their designees to resolve open CAPA issues and reduce deviations.
- Directs the Biorasi Aventura Central File Room Security Program, manages transfer of Sponsor and Biorasi records to long-term, off-site storage, and ensures that the Controlled
- Documents and Compliance and Audit sections of the N drive are maintained and that documents are accurate and consistent.
- Provide consultative direction and guidance to other company branches in order to avoid and address compliance risks and improve compliance with regulations and company policies and procedures.
- Directs Biorasi Annual Good Clinical Practice (GCP) training and conducts specialty training seminars as requested by SVP Process and Quality.
- Conducts Biorasi Compliance Improvement Meetings twice quarterly.
- Review of Branch Wise Training Modules / Matrix, staff training and assessment of training materialsReview, Trend analysis of Key Quality Indicators, conduct Root Cause
- Analysis of the Issues escalated and follow up until appropriate resolution
- Risk Assessment and Management, develop and implement Mitigation Strategies