Associate Director, QA Audits and Inspections Program

Location: United States

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Requisition Number: 3949

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 Global Talent Acquisition does at Worldwide

We are passionate and singularly focused on hiring the very best talent in the industry, whilst also providing the best possible candidate experience. Dynamic and fast-paced, we are agile, well-resourced and supported by the entire organization, which empowers us to move quickly and decisively.

 

Teamwork and collaboration is paramount, especially as a globally distributed, remote based team. We are at the forefront of Worldwide’s exciting growth and the nexus between candidates and opportunities.  

What you will do

  • Serve as a positive ambassador of the QA organization with internal and external customers.
  • Manages, plans, hosts, reports, documentation and follow up of all Worldwide Sponsor audits. 
  • Provides support to Sponsors Inspections in relation to Worldwide provided services.
  • Assists with tracking and reporting of Key Quality indications (KQI)and Quality Tolerance Limits (OTL) for the Audit and Inspection program.

What you will bring to the role

  • Excellent organizational leadership competencies, inclusive of scheduling and leading team meetings that are effective, efficient, and documented.
  • Ability to effectively communicate and influence the outcomes of decision-making process
  • Excellent skillset for influencing, being resourceful, managing conflict and negotiating.
  • Ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators.

 

Your experience

  • Bachelor’s degree with concentration in nursing, biological, physical, health, pharmacy or other related science and 8+ years of relevant GCPexperience; or equivalent work experience.
  • Broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities.
  • Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree.
  • 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.

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, QA Audits and Inspections Program

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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© Worldwide Clinical Trials 2021

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.