Senior Clinical Quality Manager - FSP Lead

IQVIA; Durham (NC); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA is seeking an experienced Quality Management professional to join our global Quality Management team. This role supports development and implementation of Quality Plans, risk management, CAPAs, and regulatory compliance across Delivery Units and sponsors.

The ideal candidate has 8+ years in clinical trial processes, strong leadership, and a solid track record in GCP/ICH, with ability to travel within the region.

Qualifications

• Expert knowledge of and experience in (minimum of 8 years) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).
• Bachelor's Degree or equivalent qualification or equivalent combination of education, training, and experience.
• Sound working knowledge of medical terminology, SOPs, ICH, GCP, applicable regulatory requirements, quality management processes.
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Good organizational, interpersonal and communication skills.
• Good judgement 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/country.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.

Responsibilities

• Adopt and implement the global 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.
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
• Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.); Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Work 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 business lines, as required by the applicable SOPs.
• Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.

Skills

Quality management

Risk management

Regulatory compliance

Leadership

Communication skills

Problem solving

Interpersonal skills

Travel ability

Education

Bachelor's degree

Tools

Microsoft Office

Job description

IQVIA is seeking an experienced Quality Management professional to join our global Quality Management team. This role supports development and implementation of Quality Plans, risk management, CAPAs, and regulatory compliance across Delivery Units and sponsors.

The ideal candidate has 8+ years in clinical trial processes, strong leadership, and a solid track record in GCP/ICH, with ability to travel within the region.