Clinical Quality Lead – GCP & Compliance

IQVIA; Maple Grove (MN); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA is seeking an experienced Clinical Quality Manager to lead global quality activities within designated units. You will work with global/regional teams to define and execute the Quality Plan, ensuring compliance with ICH, GCP, SOPs and regulatory guidelines while supporting staff on quality control and risk management.

Responsibilities include country and site oversight, risk assessments, CAPA management, inspections readiness, and collaboration with business lines to drive continuous

Qualifications

• 9+ years total experience.
• Clinical Operations background plus GCP/compliance experience.
• Strong site oversight and risk management experience.
• Oncology experience preferred.
• Knowledge of IQVIA corporate standards and SOPs.
• Strong organizational, interpersonal and communication skills.

Responsibilities

• Conduct country and site-level compliance oversight using a risk-based approach.
• Identify compliance risks, conduct site assessments, and manage CAPAs.
• Support inspections and audits while serving as the local GCP expert.
• Drive inspection readiness and compliance at the country level.
• Adopt and implement the global Quality Management Plan within the scope of the assignment; plan and execute activities; risk identification and assessment; support in planning corrective/preventive actions.
• Cooperate with stakeholders to maintain focus on quality in project delivery.
• Provide advice and support on all aspects of GCP compliance; assist in non-compliance management.
• Prepare periodic reports on quality matters and risk assessments.

Skills

GCP compliance

Risk management

Clinical operations

Leadership

Communication

Negotiation

MS Office

Travel readiness

Quality oversight

Education

Bachelor's degree or equivalent

Job description

IQVIA is seeking an experienced Clinical Quality Manager to lead global quality activities within designated units. You will work with global/regional teams to define and execute the Quality Plan, ensuring compliance with ICH, GCP, SOPs and regulatory guidelines while supporting staff on quality control and risk management.

Responsibilities include country and site oversight, risk assessments, CAPA management, inspections readiness, and collaboration with business lines to drive continuous