Vice President, Quality Assurance

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Materials, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions.

The Vice President, Quality Assurance is responsible for establishing and maintaining the Company’s global pharmaceutical quality system and providing independent Quality oversight across its product portfolio and external GxP network. This role ensures that clinical and commercial activities are conducted in accordance with applicable global regulations, cGxP requirements, regulatory commitments, and Company standards while supporting the Company’s strategic and operational objectives.

Operating within a fully outsourced model, the Vice President provides executive Quality leadership for product disposition, external partner oversight, quality-system governance, regulatory inspections, and the identification and management of significant quality and compliance risks. The role has the authority to elevate quality concerns, reject product, and suspend regulated activities when necessary to protect patients, product quality, data integrity, or regulatory compliance.

The base compensation range for this role is $320 - 350K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

• Lead the development, implementation, governance, and continuous improvement of the Company’s pharmaceutical quality system, including management review, document control, training, change control, deviations, investigations, CAPAs, complaints, and product-quality review.
• Provide independent Quality oversight of clinical and commercial manufacturing, testing, packaging, labeling, storage, and distribution activities performed by external partners.
• Serve as the Company’s final Quality authority for batch disposition and release within delegated responsibilities, while ensuring compliance with market-specific requirements, including Qualified Person certification where required.
• Ensure timely, risk-based review and approval of batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation documentation, and other records affecting product quality or disposition.
• Provide Quality oversight of process and analytical changes, technology transfers, validation activities, new product introductions, product acquisitions, and post-approval changes.
• Establish and maintain a risk-based lifecycle program for qualifying, auditing, monitoring, and requalifying CDMOs, contract laboratories, packagers, distributors, and other GxP suppliers.
• Establish quality agreements and governance processes that clearly define responsibilities, communication requirements, performance expectations, and escalation pathways with external partners.
• Monitor internal and external quality performance through meaningful metrics, management review, trend analysis, and partner governance; ensure significant risks and adverse trends…