Director, Clinical Ops Compliance & Inspection Readiness

Regulatory Jobs; United States; Presencial; USD 180.000 - 256.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan

Medical, dental and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase plan / long-term Incent

Descripción de la vacante

Exelixis seeks a Clinical Operations Compliance Director to ensure oncology trials meet ICH GCP and global regulations. You will lead risk management, CAPA oversight, vendor oversight, and inspection readiness across Clinical Operations, collaborating with QA and R&D teams.

You will guide standardized processes, provide training, and drive continuous quality improvements while advancing compliance metrics and operational excellence.

Formación

• Experience in biotech/pharmaceutical industry required.
• Experience with CROs, R&D outsourcing, purchasing or procurement roles required.
• Evidence of leadership and management skills in a role involving external suppliers.
• Prior experience leading a team.

Responsabilidades

• Lead the execution and continuous improvement of the Clinical Operations risk and issue management program.
• Partner with Clinical Operations leadership to mitigate risks impacting trial quality and compliance.
• Develop and implement functional risk management strategies and annual plans for inspection readiness.
• Review and communicate compliance trends, metrics, and inspection readiness measures to leadership.
• Oversee CAPAs with ownership, tracking, and effectiveness evaluation.
• Collaborate with Quality Assurance to support audits, inspections, and follow-up actions.
• Drive cross-study consistency in trial execution through standardized processes and templates.

Conocimientos

Leadership

Risk management

Regulatory compliance

Quality Assurance collaboration

Communication skills

Analytical thinking

Presentation skills

Influencing without authority

Educación

Bachelor's degree in related discipline

Master's degree in related discipline

Doctoral degree in related discipline

Herramientas

Microsoft Excel

Microsoft Word

PowerPoint

Outlook

Descripción del empleo

Exelixis seeks a Clinical Operations Compliance Director to ensure oncology trials meet ICH GCP and global regulations. You will lead risk management, CAPA oversight, vendor oversight, and inspection readiness across Clinical Operations, collaborating with QA and R&D teams.

You will guide standardized processes, provide training, and drive continuous quality improvements while advancing compliance metrics and operational excellence.