Associate Director, Quality Assurance - Sponsor Dedicated - U
Dedicated to CFSP Client you will provide insight which is exercisable across the organization in an advisory GCP Expert role . Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training and staff.
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
• Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional Management
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Provide expert advice on EU CTR and MHRA regulations
• Oversee documentation, reporting, and closure of compliance issues
• Participate in or lead (cross functional) teams for special projects as assigned
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements
• Work with cross functional and other quality partners to proactively identify Country level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality Management
• Bachelor's Degree
• 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience. Equivalent combination of education, training and experience.
• Prefer previous experience as a regulatory inspector (EMA/MHRA)
Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures'.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation and leadership skills.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to manage multiple activities and timelines.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com