Associate Clinical Ops Compliance & QA Lead

Exelixis, Inc.; Alameda, Northern (CA, KY); Hybrid; USD 169,000 - 239,000; Full time

Benefits offered by this job

401k plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

FSA

Bonus program

Stock purchase plan

Long-term incentives

Vacation days

Holidays

Sick days

Job summary

Exelixis, Inc. is seeking an Associate Clinical Operations Compliance Director to bolster oncology clinical research in line with ICH GCP and applicable regulations. You will partner with QA and cross-functional teams to ensure inspection readiness and robust risk management across studies.

Key duties include CAPA oversight, BIMO readiness, RBQM monitoring, and advancing quality metrics. Strong regulator knowledge and collaborative skills are essential.

Qualifications

• Bachelor’s degree in related discipline; 11+ years experience or
• Master’s degree in related discipline; 9+ years experience or
• Doctoral degree in related discipline; 5+ years experience; or equivalent combo

Responsibilities

• Assist risk and issue management for Clinical Operations.
• Collaborate with QA and other functions to ensure inspection readiness.
• Oversee CAPA owners and CAPA data updates.
• Support BIMO inspection readiness and health authority responses.
• Monitor CRO performance and risk-based monitoring signals.

Skills

Regulatory knowledge

Analytical thinking

Communication skills

Stakeholder management

Problem-solving

Time management

Cross-functional collaboration

Attention to detail

Presentation skills

Independent / self-starter

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

Doctoral degree in related discipline

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Outlook

Job description

Exelixis, Inc. is seeking an Associate Clinical Operations Compliance Director to bolster oncology clinical research in line with ICH GCP and applicable regulations. You will partner with QA and cross-functional teams to ensure inspection readiness and robust risk management across studies.

Key duties include CAPA oversight, BIMO readiness, RBQM monitoring, and advancing quality metrics. Strong regulator knowledge and collaborative skills are essential.