Global VP of Pharma Quality

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

Job summary

Veloxis Pharmaceuticals, Inc., an Asahi Kasei Group Company, seeks a Vice President of Quality Affairs to establish and maintain the global pharmaceutical quality system and provide independent quality oversight across its product portfolio and external GxP network.

The role oversees product disposition, external partner oversight, and inspection readiness, with authority to manage quality risks and escalate issues to protect patients and product integrity.

Qualifications

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related field; an advanced degree is preferred.
• 15+ years of progressively responsible Quality experience within pharmaceutical/biotechnology, including leadership for commercial products.
• Experience leading Quality in outsourced models with oversight of CDMOs and GxP suppliers.
• Broad experience across product modalities; familiarity with oral solids, biologics, or oligonucleotides preferred.
• Strong knowledge of GMP/GDP, ICH, FDA/EMA expectations, and regulatory inspections.

Responsibilities

• Lead development and governance of the pharmaceutical quality system and governance of external partners.
• Provide independent Quality oversight of clinical and commercial manufacturing, testing, packaging, labeling, storage, and distribution by external partners.
• Serve as final Quality authority for batch disposition and release with delegated responsibilities.
• Ensure timely, risk-based review of batch records, analytical results, deviations, investigations, and change controls.
• Lead regulatory inspection readiness and serve as primary Quality representative during inspections.

Skills

Quality leadership

Regulatory knowledge

GxP compliance

CDMOs oversight

Quality systems

Risk-based decisions

Education

Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or related field

Advanced degree preferred

Job description

Veloxis Pharmaceuticals, Inc., an Asahi Kasei Group Company, seeks a Vice President of Quality Affairs to establish and maintain the global pharmaceutical quality system and provide independent quality oversight across its product portfolio and external GxP network.

The role oversees product disposition, external partner oversight, and inspection readiness, with authority to manage quality risks and escalate issues to protect patients and product integrity.