Associate Director, Quality Management
hace 1 semana
This role is assigned to specific Delivery Unit(s), country/countries, sponsor(s), business unit(s), and/or particular tasks as defined by the line manager (LM). It contributes to the development and is accountable for the implementation of particular quality improvement initiatives as discussed with the relevant Head(s) of assigned business lines. Providing guidance and support to relevant key stakeholders on quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions:- Contribute to the development and support the implementation of the Quality Management Plan within the assigned scope, including planning and executing Quality Management activities, risk identification and assessment, supporting in risk mitigation and planning corrective/preventive actions.
- Cooperate closely with relevant business lines and stakeholders to maintain a focus on quality in project delivery.
- Provide advice and support on Good Clinical Practice (GCP) compliance to teams within the assigned business line.
- Work closely with teams to handle non-compliance and quality issues.
- Assist in planning corrective/preventive actions according to Standard Operating Procedures (SOPs).
- Inform the assigned business line and Quality Assurance of quality issues following SOPs.
- Collaborate with Quality Assurance and assigned business staff in case of suspected misconduct according to SOPs.
- Provide assistance during audits and regulatory inspections to teams as agreed with the line manager.
- Act as the primary contact for Quality Assurance on quality matters, attend meetings/teleconferences.
- Prepare periodic reports on quality-related matters, risk assessments, and specific quality improvement initiatives to business lines.
- Manage staff according to organization's policies and applicable regulations, including planning, directing work, appraising performance, guiding professional development, addressing employee relations issues, and resolving problems.
- Perform any other reasonable tasks as required by the role upon agreement with the Head of the relevant business line.
- Bachelor's Degree Requirement
- Typically 5-7 years of relevant experience.
- Deep knowledge of related job areas, terminology, ICH, GCP, SOPs, regulatory requirements, and quality management processes.
- Excellent organizational, interpersonal, and communication skills.
- Strong judgement, decision-making, leadership, and line management skills.
- Excellent influencing, negotiation, and problem-solving skills.
- Proficiency in Microsoft Office applications.
- Ability to work in a matrix environment, lead and motivate a clinical team, and travel when required.
- 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 have the greatest impact possible and help our customers in creating a healthier world.
We ensure equal employment opportunities for all, including veterans and candidates with disabilities.
Compliance with specific COVID-19 vaccination status requirements is essential for IQVIA and its employees to operate and provide services to customers and partners.
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