Global VP, Quality Assurance & Compliance

Asahi Kasei Corporation; Cary, Northern (NC, KY); Hybrid; USD 320,000 - 350,000; Full time

Job summary

Veloxis Pharmaceuticals, Inc. in Cary, NC, seeks a Vice President, Quality Affairs to lead the global pharmaceutical quality system and provide independent QA oversight across product portfolio and external GxP network.

The role operates within a fully outsourced model and has authority to escalate quality concerns, reject product, and suspend activities to protect patients and regulatory compliance. The candidate will build a high-performing QA organization, drive compliance with cGMP/GDP, lead

Qualifications

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or related
• Advanced degree preferred

Responsibilities

• Lead the development, governance, and continuous improvement of the Pharma quality system with management review, document control, training, change control, deviations, investigations, CAPAs, complaints, and product-quality review
• Provide independent QA oversight of clinical and commercial manufacturing, testing, packaging, labeling, storage, and distribution activities by external partners
• Serve as final QA authority for batch disposition and release within delegated responsibilities, ensuring compliance with market requirements and 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
• Provide QA 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 with external partners defining responsibilities and escalation
• Monitor quality performance through metrics, management reviews, trend analysis, and escalation of risks
• Lead regulatory inspection readiness and serve as primary QA during inspections and health-authority interactions
• Oversee data integrity, electronic records, and computerized systems within the company and external network
• Lead or support critical quality events including investigations, complaints, recalls, and regulatory notifications
• Provide QA input for BD due diligence, licensing, acquisitions, investigator-initiated studies, and promotional review
• Develop and manage QA budget, resources, and external support to meet objectives
• Build and lead a high-performing QA organization with a culture of quality and continuous improvement

Skills

Quality leadership

Regulatory compliance

GxP knowledge

CDMO oversight

Pharma quality systems

Risk-based decisions

Cross-functional leadership

Regulatory inspections

Budget management

Strategic planning

Education

Bachelor’s degree in chemical engineering / pharmaceutical sciences / chemistry / biochemistry / biology

Job description

Veloxis Pharmaceuticals, Inc. in Cary, NC, seeks a Vice President, Quality Affairs to lead the global pharmaceutical quality system and provide independent QA oversight across product portfolio and external GxP network.

The role operates within a fully outsourced model and has authority to escalate quality concerns, reject product, and suspend activities to protect patients and regulatory compliance. The candidate will build a high-performing QA organization, drive compliance with cGMP/GDP, lead