Global VP, Quality Assurance & Compliance

Asahi Kasei Therapeutics, Inc.; Cary (NC); Remote; USD 320,000 - 350,000; Full time

Job summary

Asahi Kasei Therapeutics, Inc. is seeking a Vice President of Quality Assurance to establish and maintain a global pharmaceutical quality system and provide independent QA oversight across its portfolio and external GxP network.

The role drives product disposition, external partner oversight, and inspection readiness. You will lead governance for quality systems, manage risk, and direct QA activities in a fully outsourced environment, ensuring regulatory compliance and ongoing quality

Qualifications

• Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology or related field; advanced degree preferred.
• 15+ years of progressively responsible quality experience in pharma/biotech with leadership responsibility for commercial products.
• Experience with outsourced models and oversight of CDMOs, labs, packaging, labeling, distributors, and other GxP suppliers.
• Broad experience across product modalities; familiarity with oral solids, biologics, or oligonucleotides preferred.
• Strong regulatory knowledge: GMP, GDP, 21 CFR Parts 210/211, EU GMP, ICH, FDA/EMA expectations.

Responsibilities

• Lead development and governance of the global pharmaceutical quality system.
• Provide independent QA oversight of clinical and commercial manufacturing activities by external partners.
• Serve as final QA authority for batch disposition and release within delegated responsibilities.
• Ensure timely review of records, results, deviations, investigations, and validation docs.
• Oversee process changes, tech transfers, validation, and post-approval changes.
• Establish lifecycle programs for qualification, audits, and monitoring of CDMOs and other suppliers.
• Develop quality agreements and governance with external partners.
• Monitor quality performance with metrics and trend analysis; escalate risks.
• Lead inspection readiness and respond to inquiries and remediation commitments.
• Provide QA expertise for due diligence, licensing, and promotional review as applicable.
• Build and lead a high-performing QA organization and budget.

Skills

Strategic quality leadership

GxP governance

Regulatory inspections

outsourced operations oversight

Risk assessment

Cross-functional collaboration

Budget & resource planning

Education

Bachelor's in chemical engineering or related field

Advanced degree preferred

Tools

GMP systems

QA documentation controls

Job description

Asahi Kasei Therapeutics, Inc. is seeking a Vice President of Quality Assurance to establish and maintain a global pharmaceutical quality system and provide independent QA oversight across its portfolio and external GxP network.

The role drives product disposition, external partner oversight, and inspection readiness. You will lead governance for quality systems, manage risk, and direct QA activities in a fully outsourced environment, ensuring regulatory compliance and ongoing quality