Associate Clinical Ops Compliance Leader

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

Benefits offered by this job

401k plan

Medical insurance

Dental & Vision

Life & Disability insurance

Flexible spending accounts

Annual bonus program

Stock purchase plan

Long-term incentives

Paid vacation days

Paid holidays

Sick days

Job summary

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology trials in line with ICH GCP and applicable regulations. You will partner with QA and development teams to drive risk management, issue tracking, CAPA oversight and inspection readiness across studies.

Responsibilities include supervising CAPA owners, coordinating with CROs, monitoring RBQM, and ensuring TMF readiness while contributing to strategy and governance in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in related discipline with 11+ years of related experience, or Master’s degree with 9+ years, or Doctoral degree with 5+ years.
• Experience in biotech/pharmaceutical industry required.
• Strong regulatory knowledge and ability to work independently.

Responsibilities

• Support risk and issue management for compliant study delivery.
• Contribute to functional risk management plans and inspection readiness.
• Assist CAPA owners and monitor CAPA completion.
• Collaborate with QA and cross-functional teams across R&D.
• Drive BIMO, inspection readiness and RBQM oversight.

Skills

Risk management

Issue management

GCP compliance

Regulatory knowledge

Cross-functional collaboration

Data monitoring

Inspection readiness

CAPA process

Vendor oversight

Communication skills

Education

Bachelor’s degree in life sciences

Master’s degree preferred

Doctoral degree optional

Tools

Excel

Word

PowerPoint

Outlook

Job description

Exelixis is seeking an Associate Clinical Operations Compliance Director to support oncology trials in line with ICH GCP and applicable regulations. You will partner with QA and development teams to drive risk management, issue tracking, CAPA oversight and inspection readiness across studies.

Responsibilities include supervising CAPA owners, coordinating with CROs, monitoring RBQM, and ensuring TMF readiness while contributing to strategy and governance in a fast-paced biotech environment.