Associate Director QA Audits & Inspections

Multiple Locations: Texas, United States • Florida, United States • North Carolina, United States • Arizona, United States • Nevada, United States • Oklahoma, United States

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Requisition Number: 1577

Position Title: Associate Director QA Audits & Inspections Program

External Description:

SUMMARY:  The Associate Director of QA Audits and Inspections Program is responsible for contributing to the strategic vision, oversight, planning, execution, reporting, and quality management of the QA Audits & Inspections Program.  This position supports the hosting and management of external audits of Worldwide. 
 
RESPONSIBILITIES: 

  • Champions and adheres to Worldwide’s Quality Management System (QMS)
  • Serves as a positive ambassador of the QA organization with internal and external customers
  • Participates in the crafting of the QA organizational goals and objectives as assigned
  • Ensures adherence to budgets per Worldwide processes.
  • Mentors a team of Quality professionals and ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes for all Audit & Inspection activities
  • Oversees, monitors, and reports for internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
  • Develops and drives continuous process improvements
  • Participates in the development and review of Quality Management Documents
  • Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program
  • Assists with the performance of QA audits for Vendors, Internal Process, Clinical Investigator, Document, and other audits as assigned.
  • Manages, plans, hosts, reports, documentation and follow up of all Worldwide Sponsor audits
  • Serves as a core member on the Global Regulatory Inspection Team for all Regulatory Inspections of Worldwide
  • Provides support to Sponsors Inspections concerning Worldwide provided services
  • Assists with lessons learned opportunities following inspections to allow for the transfer of knowledge and training
  • Ensures data and record management following the QMS
  • Assists in developing training material and/or delivers training related to Audits and Inspections
  • Serves as a Subject Matter Expert on QA Quality Management processes for Audits and Inspections
  • Communicates relevant regulatory intelligence that has an impact on the QMS to the QA team
  • Performs other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

 
OTHER SKILLS AND ABILITIES:

  • Ability to work with minimal supervision and guidance
  • Demonstrates excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented
  • Demonstrates excellent decision-making skills
  • Demonstrates excellent ability to effectively communicate and influence the outcomes of the decision-making process
  • Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
  • Acts with authority to drive performance and accountability
  • Demonstrates excellent skillset for influencing, being resourceful, managing conflict, and negotiating
  • Demonstrates an excellent aptitude for facilitating group or project initiatives and building team unity
  • Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
  • Demonstrates an excellent understanding of clinical research principles and processes for clinical trials
  • Demonstrates the ability to work collaboratively with cross-functional stakeholders to drive process improvements based on Quality Indicators
  • Demonstrates the ability to implement risk management strategies
     

REQUIREMENTS:

  • Possesses broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities
  • Excellent understanding of the principles for a GCP Quality Management System
  • Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree
  • Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP knowledge
  • Experience in hosting Sponsor audits
  • Previous experience with participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections
  • Excellent experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.)
  • Excellent understanding of risk-based approaches to auditing
  • Demonstrated experience for leading Sponsor Audits independently
  • Excellent understanding of the Drug Development Process
  • Ability to speak, read and write English fluently
  • Bachelor’s degree with a concentration in nursing, biological, physical, health, pharmacy, or other related science and 8+ years of relevant GCP experience. Other GxP experience is a plus.
  • Experience with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint.
  • Limited domestic and international travel required

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Associate Director QA Audits & Inspections

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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