Associate Director, Clinical Quality & Program Excellence

Takeda; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an experienced Quality Assurance professional to oversee global clinical research programs and ensure inspection readiness in multiple business units, including Oncology and PDT. The role partners with clinical teams to provide risk-based QA guidance and leads pre-approval inspection readiness and responses.

The candidate will define audit strategies, manage complex audits, and escalate critical issues to management, while mentoring CPQ staff and collaborating across QA

Qualifications

• BA/BS degree required; advanced degree preferred.
• Minimum 10 years in pharma/biotech or related health care.
• Minimum 7 years GCP-related QA or clinical trial experience.
• Extensive knowledge of ICH GCP and global regulations.
• Strong writing skills and ability to translate findings into actions.

Responsibilities

• Provide quality assurance oversight of global clinical R&D programs and ensure inspection readiness.
• Serve as strategic quality partner to clinical program teams and stakeholders.
• Define and implement risk-based audit strategy; communicate risks to management.
• Lead pre-approval inspections readiness and manage inspection responses.
• Develop risk-based audit plans and manage audits of sites, documents, vendors, and systems.
• Lead investigations into significant quality issues and coordinate CAPAs.
• Lead GCP health authority inspections and support during inspections.
• Analyze, report, and present program metrics to teams and management.
• Collaborate to identify and mitigate quality issues across programs and sites.

Skills

Excellent communication

Attention to detail

Critical thinking

Project management

Technical writing

Education

BA/BS degree

Advanced degree preferred

Job description

Takeda is seeking an experienced Quality Assurance professional to oversee global clinical research programs and ensure inspection readiness in multiple business units, including Oncology and PDT. The role partners with clinical teams to provide risk-based QA guidance and leads pre-approval inspection readiness and responses.

The candidate will define audit strategies, manage complex audits, and escalate critical issues to management, while mentoring CPQ staff and collaborating across QA