Audit Director
4 weeks ago
Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Why Worldwide
Mentors and leads a team of Quality professionals and ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes for all Audit and Inspection activities.
Participates in the crafting of the QA organizational goals and objectives as assigned.
Assists in planning and optimizing resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Audits & Inspections Program.
Leads and/or conducts various types of audits, as requested, including for cause, vendor, internal process, site audits.
Participates in the development and review of Quality Management Documents (SOPs, WIs, etc.)
Supports the management of the vendor audit program as it relates to vendor audit assignments to direct reports.
Assists with tracking and reporting of Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program.
Manages and oversees the execution and resourcing of the internal and contracted audit schedule
Support of Worldwide Sponsor audits, and lead Worldwide and Sponsor inspections, as needed.
Develops 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.
Demonstrates ability to work collaboratively with cross functional stakeholders to drive process improvements based on Quality Indicators.
Demonstrates the ability to implement risk management strategies.
Bachelor’s degree with concentration in scientific or allied health field and minimum of 10 years of relevant GCP, GVP and GcLP Auditing globally.
Minimum of 5 years of managerial experience and management of audits.
Completion of extensive GxP audit training.
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).
Experience in conducting training sessions for individuals on GxP compliance and audits
Possesses broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP, GcLP, GLP, GVP, GPP, Device and GMP knowledge.
Previous experience with FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, PMDA inspections, EMA GCP inspections, or other international Regulatory inspections in the last 3 years.
Domestic and international travel required (approximately up to 30%)
For more information on Worldwide, visit or connect with us on LinkedIn .
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