Senior Manager, Clinical Program Quality and Excellence (Oncology)

Scorpion Therapeutics; 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

Role: GCP Quality Assurance Lead overseeing global clinical research programs at Takeda, focusing on inspection readiness and compliance across multiple therapeutic areas, including Oncology, Vaccines, Plasma Derived Therapies, and Medical Marketed Products.

Responsibilities: develop risk-based audit strategies, conduct and manage audits of sites, vendors, and systems, handle inspection preparedness, lead investigations into GCP breaches, and facilitate regulatory inspections; communicate risks and findings to senior management.

Requirements: BS/BA 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; strong audit, investigation, and technical writing skills; certification in GCP QA preferred.

High-Value: global GCP compliance, clinical trial audits, inspection readiness, investigation management, cross-functional stakeholder collaboration, 30% international travel, based remotely in USA (MA).