Global Vice President, Pharmaceutical Quality

Celgard; Cary (NC); On-site; USD 320,000 - 350,000; Full time

Job summary

Asahi Kasei Therapeutics seeks a VP, Quality Assurance to lead a global pharmaceutical quality system within an outsourced model. You will oversee external partners, guide regulatory interactions, and drive continuous quality improvements to protect patients and product integrity.

The role requires 15+ years in pharma/biotech quality with leadership, deep GxP expertise, and strong governance across CDMOs and suppliers. Travel up to 25% is expected, with a focus on compliance and data integrity.

Qualifications

• Bachelor’s degree in a related scientific or engineering discipline (advanced degree preferred).
• 15+ years of pharmaceutical/biotech quality experience with leadership responsibility for commercial products.
• Extensive outsourced-model experience with CDMOs, contract labs, packaging providers, distributors, and other GxP suppliers.

Responsibilities

• Lead development, governance, and continuous improvement of the pharmaceutical quality system.
• Provide independent Quality oversight of clinical and commercial manufacturing and testing by external partners.
• Serve as final Quality authority for batch disposition and release with delegated responsibilities.
• Ensure timely, risk-based review and approval of batch records, analytical results, and investigations.
• Oversee quality changes, tech transfers, validations, new products, and post-approval changes.
• Establish lifecycle risk-based programs for qualifying and monitoring GxP suppliers.
• Create quality agreements and governance with external partners.
• Monitor quality performance through metrics and governance; escalate risks and trends.
• Lead regulatory inspection readiness and respond to inspections and commitments.
• Ensure data integrity and proper documentation across systems and external network.

Skills

Quality leadership

Regulatory inspections

GxP compliance

CDMO oversight

FDA/EMA knowledge

Cross-functional leadership

Data integrity

Education

Bachelor’s degree in chemical engineering or related field

Advanced degree preferred

Job description

Asahi Kasei Therapeutics seeks a VP, Quality Assurance to lead a global pharmaceutical quality system within an outsourced model. You will oversee external partners, guide regulatory interactions, and drive continuous quality improvements to protect patients and product integrity.

The role requires 15+ years in pharma/biotech quality with leadership, deep GxP expertise, and strong governance across CDMOs and suppliers. Travel up to 25% is expected, with a focus on compliance and data integrity.