Clinical FSP Quality Manager

IQVIA•Durham, NC

2d•$62,800 - $216,000

About The Position

This individual-contributor role supports designated delivery units, sponsors, business lines, and/or specific tasks. Working with global or regional Quality Management teams, functional teams, and other stakeholders, the role helps define and implement the global Quality Management Plan according to the assignment’s needs. It supports clinical staff and other stakeholders in improving compliance with ICH, GCP, SOPs, KPIs, regulatory requirements, and guidelines, and provides advice on quality control, risk management, and corrective and preventive actions. The role adopts and implements quality plans, performs risk identification and assessment, supports risk mitigation and quality improvement, and contributes to delivery-unit- or sponsor-specific quality and risk management programs. It advises teams on GCP compliance, supports management of non-compliance and quality issues, communicates issues to relevant quality and business functions, and works with Quality Assurance on suspected misconduct. As agreed, it may assist with audits and regulatory inspections. The role serves as the Quality Assurance contact for assigned matters, attends relevant meetings, and prepares periodic reports on quality matters, risk assessments, and improvement initiatives.

Requirements

At least 8 years of expert knowledge and experience in clinical development processes, including clinical trial design, planning, start-up, conduct, analysis, and reporting.
Bachelor’s degree or equivalent qualification, or an equivalent combination of education, training, and experience.
Sound working knowledge of medical terminology, SOPs, ICH, GCP, applicable regulatory requirements, and quality management processes.
Knowledge of national and international regulations and drug development processes.
Knowledge of CRO or pharmaceutical industry operations.
Knowledge of IQVIA corporate standards and SOPs.
Good organizational, interpersonal, and communication skills.
Good judgment and decision-making skills.
Strong influencing and negotiation skills.
Strong computer skills, including Microsoft Office applications.
Excellent problem-solving skills.
Ability to travel within the region or country.
Ability to lead and motivate a clinical team.
Ability to establish and maintain effective working relationships with co-workers, managers, and clients or customers.

Responsibilities

Adopt and implement the global Quality Management Plan within the assignment, including planning and executing quality activities.
Identify and assess risks through data review and quality-control processes.
Support risk mitigation, corrective and preventive action planning, and quality improvement.
Support assigned business-line management and staff in enhancing effectiveness and maintaining a focus on quality in project delivery.
Contribute to development and implementation of Delivery Unit- or sponsor-specific Quality Management Plans and Risk Management Programs, and monitor their implementation and delivery.
Advise and support teams and stakeholders on Good Clinical Practice compliance.
Work with teams to manage non-compliance and quality issues and support corrective and preventive action planning according to SOPs.
Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
Work with Quality Assurance and assigned business staff on suspected misconduct, as required by applicable SOPs.
Assist teams during audits and regulatory inspections to the extent agreed with business lines and as required by applicable SOPs.
Act as the primary Quality Assurance contact for quality matters within the assignment and attend meetings or teleconferences.
Prepare periodic business-line reports on quality matters, risk assessments, and quality improvement initiatives.
Perform other reasonable tasks as required by the role, upon agreement with the line manager.