Associate Director, Audits and Inspections Program
Location: United States
Requisition Number: 4642
Position Title: Associate Director QA Audits & Inspections Program
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, Audits and Inspection Program 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
- 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.
- 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.
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!
Employment Type: Regular
Community / Marketing Title: Associate Director, Audits and Inspections Program
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: San Antonio, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.