This highly visible role within the IQVIA QA function is an opportunity to positively influence quality and compliance for delivery of one of the most significant services the company offers (i.e. Global Site Activation and Clinical Site Management). The successful candidate will report in to the Chief Medical and Scientific Officer, working to support the introduction of cutting-edge technological advances transforming the Clinical Trial process.
Accountable for driving the Quality Assurance delivery program within assigned region. Oversee support of customer / functional accounts, audit and inspection programs, business analytics, and QA Quality Management Systems. Responsible for ensuring teams within the region have clear focus and understanding of QA strategy and that services are executed and delivered to the highest standards and within budget.
We are looking for that passion and drive. Prime examples of core QA work. leadership- navigated around organizations. Regulatory inspections , QA and Leadership
• Oversee direction of Quality Assurance Program, as assigned
• Ensure quality assurance organization and operating procedures are in place to support assigned program(s) of work
• Oversee QA delivery by ensuring staff have a clear focus and understanding of QA strategy and that services are executed and delivered with effective and efficient processes to follow
• Ensure there is regular assessment and oversight of performance and that services are executed to the highest standards of compliance with regulations, standard operating procedures and principles of process management
• Ensure there is a continuous improvement program to optimise processes
• Ensure the program of work is delivered within budget, time frame and resourcing constraints
• Identify risks to delivery of the program of work and manage the mitigations
• Identify opportunities for improvements, efficiencies, and elimination of redundant activities, ensuring the program of work continues to represent excellent value to te business in return on investment
• Support the Global Head of QA and collaborate with peers in collective responsibility for the delivery of all QA services
• Undertake other essential and critical operational duties in line with department need, e.g, Host customer audits and /or regulatory inspections, and oversight preparations of prepare corrective action plans and effectiveness checks
• Participate in or lead teams for special projects as assigned. Teams may be cross functional
• Ensure industry standards training of department staff for regulatory inspections
• Supervise consultation, guidance, tracking, and metrics system
• Interface with senior management to discuss quality and compliance issues
• Interface with business development and operations to identify business opportunities
• Recommend staff management actions in accordance with organization's policies and applicable laws.
• Recommendations include training, coaching, and mentoring employees, planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems
• Performs other duties as needed.
• Bachelor's Degree
• 15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation skills.
• Ability to influence and guide others.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.