IQVIA

Clinical FSP Associate Director, Quality - Client Dedicated

IQVIA

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Contributes to the development and supports implementation of the Quality Management Plan within the scope of the assignment; 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