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 over 3,500+ 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.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Senior Director QA Audits and Inspection Programs does at Worldwide
The Sr. Director of QA Audit and Inspection Program is responsible for the Strategic Vision, oversight, planning, execution, reporting and quality management of QA Audit & Inspection Program reporting to the EVP Global Head of Quality.
What you will do
- Act as the QA Global head for the QA Audits & Inspections reporting directly to the EVP Global Head of Quality
- Plans, adjusts, manages and optimizes all resources (budgets, staff and technologies) for the advancement of the QA’s goals and objectives for the Audit & Inspection Program
- Oversees, monitors and reports on all internal and external QA audits to ensure timely completion of applicable CAPAs to prevent reoccurrence and to drive process improvements
- Defines, monitors, tracks and reports Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the Audit & Inspection Program
- Oversees the management, planning, hosting, reporting, documentation and follow up of all GCP Regulatory Inspections and Sponsor audits
- Serves as the Subject Matter Expert on QA Quality Management Processes for Audits and Inspections
What you will bring to the role
- Demonstrates excellent organizational leadership competences, inclusive of scheduling and leading team meetings that are effective, efficient and documented
- Demonstrates excellent project management and decision-making skills
- Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
- 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
- Demonstrates the ability to implemented risk management strategies
- Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international
- Regulatory inspections is required
Your experience
- Excellent understanding of the principles for a GCP Quality Management System
- Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, AIFA CRO Decree
- 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 required
- Previous experience in preparing an organization for GCP Regulatory Inspection and being the primary lead of GCP Inspections for MHRA, Health Canada, EMA, or FDA in the last 2 years.
- Demonstrated experience for implementing GCP inspection readiness activities and tools in past 2 years.
- Excellent experience in conducting QA Audits, specifically GCP for each type (Clinical Investigator Audits, Vendor Audits, Internal Process Audits) in last 5 years.
- Excellent understanding or risk-based approaches to auditing
- Demonstrated experience for leading Sponsor Audits independently
- Previous experience in trending and analysis methodologies
- Understanding of 21 CFR Part 11 regulations and other international guidelines specifically addressing Computer Systems Electronic Record/Electronic Signature (ERES)
- Excellent understanding of the Drug Development Process
- Proven experience in developing, managing and complying with annual budgets
- Ability to speak, read and write English fluently
- M.S. in a scientific or allied health filed and 7+ years of relevant GCP, GcLP, GLP, GVP and GPP experience
Or
- Four-year college curriculum with concentration in nursing, biological, physical, health, pharmacy or other related science and 10+ years of relevant GCP, GLP, GVP experience
- And ≥ 8-10 years of strong managerial experience
- IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint.
- Domestic and international travel required (approximately 25%)
We love knowing that someone is going to have a better life because of the work we do.
For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
