Clinical Ops Compliance Director: RBQM & Readiness

Regulatory Jobs; United States; On-site; USD 169,000 - 239,000; Full time

Job summary

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research in line with ICH GCP and global regulations. You will partner with QA, Clinical Development, Data Management and other teams to drive inspection readiness and cross-study consistency.

The role focuses on risk management, issue handling, vendor oversight, and site/data monitoring with stakeholder collaboration across R&D.

Qualifications

• Biopharmaceutical industry experience required.
• Understanding of external scientific, legal and regulatory environment.
• Strong analytical, strategic thinking and problem-solving skills.
• Ability to work independently with minimal supervision and collaborate cross-functionally.

Responsibilities

• Support risk and issue management for Clinical Operations and compliant study delivery.
• Assist in creating annual functional risk management plans and ensure inspection readiness.
• Support CAPA owners and track follow-up for CAPA activities.
• Coordinate with QA and other R&D functions to address quality issues.
• Lead or support BIMO and health authority inspection responses.

Skills

Regulatory knowledge

GCP & ICH familiarity

Risk & issue management

CAPA management

Inspection readiness

Cross-functional collaboration

Analytical thinking

Project management

Communication skills

Education

Bachelor’s degree

Master’s degree

Doctoral degree

Equivalent experience

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Microsoft Outlook

Job description

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology clinical research in line with ICH GCP and global regulations. You will partner with QA, Clinical Development, Data Management and other teams to drive inspection readiness and cross-study consistency.

The role focuses on risk management, issue handling, vendor oversight, and site/data monitoring with stakeholder collaboration across R&D.