Associate Director, Audits and Inspection Program - Nottingham - Remote

Location: Nottingham, England, United Kingdom

Notice

This position is no longer open.

Requisition Number: 4628

Position Title: Associate Director QA Audits & Inspections Program

External Description:

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

 

What the Associate Director QA Audits & Inspections does at Worldwide

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 hosting and management of external audits of Worldwide.

 

What you will do

  • 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 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
  • 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

 

What you will bring to the role

  • 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 ability to effectively communicate and influence the outcomes of decision-making process
  • Communicates professionally, concisely, clearly, and consistently to external and internal customers both verbally and in writing
  • 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 ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators

 

Your experience

  • 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
  • Previous experience with participating in one or more of the following regulatory inspections: FDA GCP 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
  • Bachelor’s degree with concentration in nursing, biological, physical, health, pharmacy or other related science and 8+ years of relevant GCP experience; or equivalent work experience.
  • Domestic and limited international travel, as required

 

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers. 

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers! 

 

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Employment Type: Regular

Community / Marketing Title: Associate Director, Audits and Inspection Program - Nottingham - Remote

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.

Location_formattedLocationLong: Nottingham, GB

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