Associate Director Quality Assurance - GCP Clinical Trials - Based in South Africa

PROFILE

Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global levels.

RESPONSABILITIES

• 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 and Global QA Management
• Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
• Oversee documentation, reporting, and closure of compliance issues
• Support Quality Management in proposal reviews and reporting QA metrics
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned.

REQUIREMENTS

• 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience. Equivalent combination of education, training and experience.
• 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.
• Homebased - Based in South Africa

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