Associate Director Quality Management

About the position Join IQVIA on our mission to drive healthcare forward! We are recruiting for a Clinical FSP Associate Director Quality - Client Dedicated; open to candidates across USA and offering remote working. The Clinical FSP Associate Director Quality - Client Dedicated, will contribute to the regional development and implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines and provide advice / support to key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions. Why IQVIA? Professional Development - resources that promote your career growth Work-life Balance - leaders that support flexible work schedules Growth Potential - clear pathways to success Collaboration - teams that work together to achieve common goals Variety - dynamic work environments that expose you to new experiences Best-in-class Training - programs to help you build knowledge and gain skills Awards FORTUNE Magazine's World's Most Admired Companies list for the third year in a row - Ranked #1 in Its Category for the Second Consecutive Year

Responsibilities

• Contributes to the development and supports implementation of the Quality Management Plan within the scope of the assignment this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness in project delivery.
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance. Works in close cooperation with teams to manage non-compliance, quality issues Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs. Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs. Acts as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives. Manages 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.
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.

Requirements

• Bachelor's degree in life sciences or equivalent with a minimum of 5-7 years’ prior relevant experience; or equivalent combination of education, training and experience.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English

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