Director QA Audits & Inspections Program - UK - Home Based

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 a Director of QA Audits and Inspections Program does at Worldwide

The Director of QA Audits and Inspections Program is responsible for contributing to the Strategic Vision, oversight, planning, execution, reporting and quality management of QA Audits & Inspections Program. Reports to the Senior Director of QA Audits and Inspections Program.

What you will do

• Champions and adheres to Worldwide’s Quality Management System (QMS)
• May participate and present at the Quality Management Council (QMC)
• Serves as a positive ambassador of the QA organization with internal and external customers
• 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 Audit & Inspection Program
• 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
• Approves work related travel and expenses reports for direct reports while staying on budget and in compliance with Worldwide Travel Policy
• 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
• Manages, plans, hosts, reports, documentation and follow up of all Worldwide Sponsor audits
• Serves as a core member on the Global Regulatory Inspection Team for all Regulatory Inspections of Worldwide
• Provides support to Sponsors Inspections in relation to Worldwide provided services
• Serves as a core member or supports the Global Regulatory Inspection Committee (GRIC)
• Assists with lessons learned opportunities following inspections to allow for transfer of knowledge and training
• Ensures data and record management in accordance with the QMS
• 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
• Communicates relevant regulatory intelligence that has impact on the QMS to the QA team
• Participates in employee performance appraisals as per Worldwide processes

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 decision-making skills
• 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
• Acts with authority to drive performance and accountability
• Ability to lead a team of individuals with a clear vision and defined purpose
• 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
• Demonstrates the ability to implement risk management strategies

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, GcLP, GLP, GVP, GPP, Device and GMP knowledge
• Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, or other international Regulatory inspections in the last 3 years
• 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)
• Excellent understanding of risk-based approaches to auditing
• Demonstrated experience for leading Sponsor Audits independently
• Previous experience in trending and analysis methodologies
• Excellent understanding of the Drug Development Process
• Ability to speak, read and write English fluently
• M.S. in a scientific or allied health filed and 5+ years of relevant GCP, GcLP, GLP, GVP and GPP experience

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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