Global Clinical Quality Manager (FSP) - Compliance & Risk

NCBioImpact; Durham (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

IQVIA is a global leader in clinical research services, delivering quality management across delivery units and sponsor programs. The role focuses on defining and adopting the global Quality Plan, driving risk assessments, CAPAs, and regulatory compliance to support high-integrity project delivery.

As an individual contributor, you will collaborate with global teams, ensure SOP adherence, and participate in audits and inspections as required, with English fluency as a key requirement.

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).
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Excellent problem solving skills.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
• Fluent in English.

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.
• 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

Clinical trial design

Quality management

GCP compliance

Regulatory knowledge

Relationship building

Education

Bachelor's degree in life sciences

Job description

IQVIA is a global leader in clinical research services, delivering quality management across delivery units and sponsor programs. The role focuses on defining and adopting the global Quality Plan, driving risk assessments, CAPAs, and regulatory compliance to support high-integrity project delivery.

As an individual contributor, you will collaborate with global teams, ensure SOP adherence, and participate in audits and inspections as required, with English fluency as a key requirement.