Global VP of Quality & Compliance

Asahi Kasei Therapeutics; Cary (NC); On-site; USD 320,000 - 350,000; Full time

Job summary

Asahi Kasei Therapeutics in the United States seeks a Vice President of Quality Assurance to design and oversee the global pharmaceutical quality system and ensure compliance across a heavily outsourced portfolio. You will lead QA governance, risk assessment, and regulatory readiness, partnering with external CDMOs and internal stakeholders to safeguard product quality and patient safety.

The role requires deep GMP/GDP expertise, extensive leadership experience, and the ability to communicate

Qualifications

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or related field; advanced degree preferred.
• At least 15 years of progressively responsible quality experience in pharma/biotech with leadership for commercial products.
• Experience leading quality in outsourced models with CDMOs and packaging/distributors.
• Strong knowledge of GMP, GDP, ICH, FDA/EMA expectations and regulatory inspections.

Responsibilities

• Lead the development and governance of the pharma quality system and continuous improvement.
• Provide independent QA oversight of clinical and commercial manufacturing and testing with external partners.
• Serve as final quality authority for batch disposition and release.
• Ensure timely review of batch records, deviations, investigations, changes, CAPAs and validation documentation.
• Lead regulatory inspection readiness and responses.

Skills

Quality leadership

GxP compliance

Regulatory inspections

Outsourced model management

Cross-functional leadership

Data integrity

Risk assessment

Education

Bachelor's degree in a related scientific or engineering discipline

Advanced degree preferred

Job description

Asahi Kasei Therapeutics in the United States seeks a Vice President of Quality Assurance to design and oversee the global pharmaceutical quality system and ensure compliance across a heavily outsourced portfolio. You will lead QA governance, risk assessment, and regulatory readiness, partnering with external CDMOs and internal stakeholders to safeguard product quality and patient safety.

The role requires deep GMP/GDP expertise, extensive leadership experience, and the ability to communicate