Associate Director, Clinical Program Quality and Excellence (Oncology)

Scorpion Therapeutics; United States; Remote; USD 150,000 - 200,000; Full time

Job summary

Takeda is seeking a Senior Clinical Quality Assurance Lead to oversee global clinical research programs across multiple divisions. You will drive inspection readiness, strategic quality guidance, and GCP compliance across trials.

Remote in Massachusetts with ~30% travel, including international assignments. You will develop risk-based audit strategies, manage site and vendor audits, lead regulatory inspections, and investigate quality issues.

Qualifications

• BA/BS in life sciences or related field; advanced degree preferred.
• 10+ years in pharma/biotech with 7+ years in GCP QA or clinical trials.

Responsibilities

• Develop risk-based audit strategies for global trials.
• Manage site and vendor audits.
• Lead GCP inspection readiness and responses.
• Investigate quality issues and CAPA closure.
• Facilitate regulatory audits and health authority inspections.

Skills

ICH GCP

Regulatory compliance

Audit management

Risk mitigation

Education

Bachelor's degree in life sciences

Job description

Role

Senior Clinical Quality Assurance Lead overseeing global clinical research programs within Takeda's R&D, Plasma Derived Therapy, Vaccines, Oncology, and Medical Marketed Products divisions.

Objectives

Ensuring inspection readiness, providing strategic quality guidance, and leading GCP compliance efforts.

Responsibilities

Developing risk-based audit strategies, managing site and vendor audits, leading GCP inspection readiness and responses, investigating quality issues, and facilitating regulatory audits and health authority inspections.

Qualifications

BA/BS (advanced degree preferred), 10+ years in pharma/biotech, with 7+ years in GCP QA or clinical trials.

Essential Skills

Deep knowledge of ICH GCP, global regulations, audit management, and risk mitigation.

Preferred Certifications

GCP QA registration.

High-value specifics

Expertise in clinical trial oversight, GCP compliance, and regulatory inspection management; experience with global audits, investigations, and cross-functional collaboration.

Work setup

Remote in Massachusetts with approximately 30% travel, including international.