Clinical Quality & Compliance Lead

IQVIA; San Francisco (CA); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA is a global leader in clinical research services, seeking an experienced quality professional to lead and coordinate quality management for designated Delivery Units and sponsors. The role collaborates with global/regional teams to define and implement the global Quality Plan, ensuring adherence to ICH, GCP, SOPs and regulatory standards.

The position emphasizes risk-based oversight, CAPA management, inspections support, and readiness across country-level operations, with strong

Qualifications

• 9+ years total experience.

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, including planning and executing activities, risk assessment, and corrective/preventive actions guidance.
• Cooperate with relevant business and stakeholders to maintain 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 implementation.
• Provide advice and support to teams on all aspects of GCP compliance.
• Work with teams to manage non-compliance and quality issues per SOPs.
• Inform Quality Management and QA of quality issues per SOPs.
• Work with QA and staff on suspected misconduct as required by SOPs.
• Assist during audits/regulatory inspections as agreed with business lines per SOPs.
• Act as primary QA contact at the assignment level, attending meetings/teleconferences.
• Prepare periodic reports on quality-related matters, risk assessments and improvement initiatives.
• Perform any other reasonable tasks as required by the line manager.

Skills

Site oversight

Risk management

Communication skills

Judgement & decision-making

Negotiation skills

Microsoft Office

Problem solving

Travel readiness

Team leadership

Relationship building

Fluent English

Education

Bachelor’s Degree

Tools

IQVIA SOPs

Job description

IQVIA is a global leader in clinical research services, seeking an experienced quality professional to lead and coordinate quality management for designated Delivery Units and sponsors. The role collaborates with global/regional teams to define and implement the global Quality Plan, ensuring adherence to ICH, GCP, SOPs and regulatory standards.

The position emphasizes risk-based oversight, CAPA management, inspections support, and readiness across country-level operations, with strong