Remote Global GCP QA Lead: Inspection Readiness & Audits

Takeda; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Takeda is seeking a GCP Quality Assurance Lead to oversee global clinical research programs, focusing on inspection readiness and compliance across oncology, vaccines, plasma-derived therapies, and medical marketed products.

Responsibilities include developing risk-based audit strategies, auditing sites, vendors and systems, leading investigations into GCP breaches, and coordinating regulatory inspections; regular updates to senior management.

Qualifications

• BS/BA required with 7+ years in pharma/biotech.
• At least 5 years in GCP QA or related clinical trial experience.
• Extensive knowledge of ICH GCP R2 and global regulations.
• Certification in GCP QA preferred.

Responsibilities

• Develop risk-based audit strategies.
• Conduct and manage audits of sites, vendors, and systems.
• Handle inspection preparedness.
• Lead investigations into GCP breaches.
• Facilitate regulatory inspections.
• Communicate risks and findings to senior management.

Skills

GCP QA

Audit management

Inspection readiness

Investigation management

Regulatory inspections

Risk communication

Education

Bachelor's degree

Job description

Takeda is seeking a GCP Quality Assurance Lead to oversee global clinical research programs, focusing on inspection readiness and compliance across oncology, vaccines, plasma-derived therapies, and medical marketed products.

Responsibilities include developing risk-based audit strategies, auditing sites, vendors and systems, leading investigations into GCP breaches, and coordinating regulatory inspections; regular updates to senior management.