Senior Director, GCP QA & Inspection Readiness

International Executive Service Corps; San Francisco, Northern (CA, KY); Hybrid; USD 260,000 - 320,000; Full time

Benefits offered by this job

Health Insurance

401(k) Match

Paid Time Off

Wellness Programs

Parental Leave

Job summary

Nektar Therapeutics in San Francisco is seeking a Sr. Director of GCP Quality Assurance to lead the design and maintenance of quality systems supporting clinical trial quality and regulatory compliance.

This role serves as a senior QA partner for development programs, guiding risk-based audits and ensuring robust CAPA processes. You will drive inspection readiness, provide cross-functional QA support across Phase I–IV, and mentor staff to strengthen quality and operational effectiveness in a

Qualifications

• Experience in clinical quality documentation and GCP auditing.
• Deep knowledge of ICH-GCP and global clinical regulations.
• Familiar with quality risk management and data integrity practices.

Responsibilities

• Oversees QA systems for clinical trial quality and GCP compliance.
• Generates and reviews documents for clinical quality systems and trial oversight.
• Leads investigations and resolution of protocol deviations, CAPAs, inspection findings, and vendor/site quality concerns.
• Provides QA leadership for Phase I–IV development, including inspection readiness and cross-functional support.
• Reviews risk assessments, Sponsor and Vendor Oversight Plans, and quality metrics.

Skills

ICH-GCP knowledge

Quality systems

Auditing

Leadership

Regulatory compliance

Risk management

Data integrity

Education

Bachelor's degree in scientific discipline

Advanced degree preferred

Job description

Nektar Therapeutics in San Francisco is seeking a Sr. Director of GCP Quality Assurance to lead the design and maintenance of quality systems supporting clinical trial quality and regulatory compliance.

This role serves as a senior QA partner for development programs, guiding risk-based audits and ensuring robust CAPA processes. You will drive inspection readiness, provide cross-functional QA support across Phase I–IV, and mentor staff to strengthen quality and operational effectiveness in a