Vice President, Quality Assurance

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

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.

Job Description

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 oversee and evaluate quality concerns, reject product, and suspend regulated activities when necessary to protect patients, product quality, data integrity, or regulatory compliance.

Summary of Key Responsibilities

• 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 are appropriately escalated and addressed.
• Lead regulatory inspection readiness and serve as the primary Quality representative during inspections and health‑authority interactions. Oversee the development and completion of inspection responses and remediation commitments.
• Ensure appropriate oversight of data integrity, electronic records, computerized systems, and documentation practices within the Company and across its external GxP network.
• Lead or support critical quality events, including significant investigations, product-quality complaints, recalls, market actions, and regulatory notifications.
• Provide Quality expertise for business‑development due diligence, licensing activities, product acquisitions, investigator‑initiated studies, and promotional review, as applicable to the Company's procedures and the role's assigned scope.
• Develop and manage the Quality Affairs budget, organizational capabilities, resource plans, and external support required to meet portfolio and corporate objectives.
• Build and lead a high‑performing Quality organization while fostering a culture of quality, accountability, compliance, transparency, and continuous improvement across the Company.

Required Qualifications and Skills

• Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline; an advanced degree is preferred.
• At least 15 years of progressively responsible Quality experience within the pharmaceutical or biotechnology industry, including significant leadership responsibility for commercial products.
• Demonstrated experience leading Quality in a fully or substantially outsourced operating model, with oversight of CDMOs, contract laboratories, packaging and labeling providers, distributors, and other GxP suppliers.
• Broad experience across multiple product modalities and manufacturing platforms. Experience with at least two of the following is strongly preferred: oral solid dosage forms, biologics, and oligonucleotide products.
• Extensive experience with batch disposition, pharmaceutical quality systems, supplier quality, investigations, change control, CAPA, validation oversight, product complaints, and inspection readiness.
• Strong knowledge of applicable global GMP and GDP requirements, including 21 CFR Parts 210 and 211, relevant EU regulations and GMP guidance, ICH guidelines, and applicable FDA and EMA expectations.
• Experience interacting directly with regulatory authorities and successfully leading regulatory inspections, responses, remediation activities, and compliance commitments.
• Demonstrated ability to make independent, risk‑based product-quality and compliance decisions using sound scientific and regulatory judgment.
• Experience leading managers and professional staff and establishing effective Quality governance across cross‑functional and external‑partner organizations.
• Strong executive presence and the ability to communicate complex quality risks, recommendations, and decisions clearly to senior leadership, boards, regulators, partners, and technical teams.
• Excellent leadership, negotiation, organizational, analytical, and problem‑solving skills, with the ability to manage multiple priorities in a dynamic environment.

Travel Requirements: 25%, including international travel#LH-EM2 #LI-LH1 #Hybrid

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.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.