Manager, Quality Assurance

Location: Aventura, FL, United States
Date Posted: 03-01-2017
Headquartered in Aventura, Florida, with regional offices and operations across North America and around the world, Biorasi is an award-winning fast growing, full-service, global CRO that delivers Clinical Research Optimized™ to the world's leading biotech and pharmaceutical companies.

Biorasi hires talent and personality, not position holders. We’re a non-traditional work environment requiring only top performers.  Every team member is a stock-holding owner and our culture reflects it.

Unlimited potential for professional, financial and personal growth. If you are after broad and growing responsibilities coupled with full authority, are keen on doing the job your way, without bureaucracy getting in the way of key decisions, and truly believe that a well-structured operational infrastructure is one of the key components to a company’s success, then this unique opportunity is for you.

This is a remarkable opportunity to dedicate yourself to leading a vital function of a growing company and benefiting professionally and financially from your accomplishments. If you have an entrepreneurial mind-set, a passion for achievement and are looking for a place to explore your potential, Biorasi wants to talk to you now.
 
Our Culture
It’s really the people that make Biorasi the kind of company it is. We hire people who are smart and determined, and we favour ability over experience. Although our employees share common goals and visions for the company, we hail from all walks of life and speak dozens of languages, reflecting the global audience that we serve. We strive to maintain the open culture often associated with start-ups, in which everyone is a hands-on contributor and feels comfortable sharing ideas and opinions.
  • 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 Biorasi’s 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 SOP’s and Forms, ensures consistency and relevance of content across all SOP’s, audits SOP’s against the biorasi’s process methodology to identify areas of inconsistency, and addresses any audit findings by updating SOP’s 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 materials
  • Review, 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
 
Qualifications and Experience Required:
  • Bachelor’s degree in a science, business or accounting related field, Master’s degree preferred.   
  • 4+ years GCP quality assurance and/or audit experience at a Pharma Organization or CRO.
  • Experienced with conducting and directing Internal Audits, Investigator Audits and Vendor Audits.   
  • In-depth practical knowledge of FDA regulations and ICH guidelines.
  • Ability to travel up to 20% domestic and international travel.
  • Strong communication, planning, negotiation, presentation and team player skills.
Location: Aventura, Florida
Candidate should either reside in Southern Florida or should be “very interested” in relocating to Florida.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

 
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