
Clinical FSP Associate Director Quality
4 дней назад
- 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
- 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.
Required Knowledge, Skills and Abilities
- 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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
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