Director, Quality Management - Sponsor Dedicated - UK
This role will be assigned to a designated client.
The purpose of this role is to oversee a global Quality Team clearly defining the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of the assignment and business line; to assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.
This role coordinates and oversees Quality activity within the scope of assignment, provides advice, supports staff, and other relevant key stakeholders with regards to quality control, risk management, and corrective/preventive actions.
• Contribute to the development of or develop the global Quality Plan, the quality management processes, methodology, tools and any preventative action required on the global level. Coordinate or participate in global cross-functional working parties focused on quality assessment and improvement, as required. Develop, supervise implementation or implement the Quality Plan within the scope of assignment, deploy Quality Managers/Specialists across the region in agreement with Operational management, oversee the quality management activities including: Risk identification, assessment and ad hoc management. Preventative actions and guidance for improvement. Monitoring of compliance with the global strategy. Evaluation of the impact made by the quality management activities. Measurement of performance;
• Cooperate closely with the relevant stakeholders, support maintaining focus on country quality delivery. Contribute to the development of or develop a specific Quality Management Plan and Risk Management Program according to the scope of assignment to complement global strategy, monitor the implementation and delivery. Ensure adequate and dedicated communication with Site Management/Operational Management and Quality Assurance, as required. Provide advice and support to Site Management and/or other stakeholders related to quality. Support operational teams to manage and prevent (e.g. review, escalate) quality issues. Be the primary contact with Quality Assurance for global or regional and/or strategic matters.
• Serve as Quality Advisor, Reviewer and Approver for global quality issue investigations and CAPA management process, risk mitigation, inspection readiness
• Participate in quality management reviews, risk reviews, and other study/TA/Asset level quality reviews to drive Clinical development and Operations Quality deliverables
• Perform line manager activities overseeing approximately 9 staff members
• If job holder is delegated to line manager: May manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters. ;
• Perform any other appropriate tasks as required by the role. ;
• Performs any other reasonable tasks as required by the role.;
• Bachelor's Degree Life sciences or equivalent scientific subject
• 10 years experience in Clinical Quality, Clinical Operations or Quality Management.
• Sound working knowledge of medical terminology, Good Clinical Practice (GCP), Local regulations, GxP Knowledge and quality improvement initiatives and processes.
• Knowledge of National and International Regulations and Drug Development process.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgment and decision-making skills.
• Excellent leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office and Clinical Management applications.
• Excellent problem solving skills.
• Excellent ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel extensively globally/ within the region.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.
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