Associate Quality Management Director, SMO Operations

IQVIA•Durham, NC

About The Position

This role is an individual contributor assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). The Associate Quality Management Director contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant assigned business lines. They provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions. The role involves planning and executing Quality Management activities, identifying and assessing risks through data review and quality control processes, and providing support in risk mitigation, planning corrective/preventive actions, and guidance for improvement. The individual will support assigned business line management and staff to enhance effectiveness in project delivery, cooperate closely with relevant business lines and other stakeholders to maintain focus on quality, and provide advice and support on all aspects of Good Clinical Practice (GCP) compliance. They will manage non-compliance and quality issues, assist in planning corrective/preventive actions according to SOPs, and inform the assigned business line and Quality Assurance of quality issues. The role also involves working closely with Quality Assurance and assigned business staff in cases of suspected misconduct, providing assistance during audits and regulatory inspections, acting as the primary contact for Quality Assurance on quality matters, and preparing periodic reports on quality-related matters, risk assessments, and specific quality improvement initiatives.

Requirements

Bachelor's Degree or Equivalent Experience
5-7 years of prior relevant 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.

Responsibilities

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 and 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.
Performs any other reasonable tasks as required by the role.