Global Quality Executive, Pharma (VP Level)

Veloxis Pharmaceuticals, Inc.; Cary (NC); On-site; USD 320,000 - 350,000; Full time

Job summary

Veloxis Pharmaceuticals, Inc. in Cary, NC, seeks a Vice President, Quality Affairs to establish and maintain the company’s global pharmaceutical quality system and provide independent quality oversight across its product portfolio and external GxP network.

This role operates within a fully outsourced model and requires executive leadership for batch disposition, partner governance, regulatory inspections, data integrity, and risk-based quality decisions that protect patients and ensure

Qualifications

• Bachelor’s degree in related scientific field; advanced degree preferred.
• 15+ years of progressively responsible quality experience in pharma/biotech.
• Experience leading quality in outsourced models with CDMOs and suppliers.
• Broad experience across product modalities; prefer two of: solids, biologics, oligonucleotides.
• Extensive experience with batch disposition, QMS, supplier quality, investigations, CAPA, validation, inspection readiness.
• Knowledge of GMP/GDP requirements including 21 CFR 210/211, EU GMP, ICH, FDA/EMA.
• Experience interacting with regulatory authorities and leading inspections.
• Ability to make independent, risk-based quality decisions; communicate to leadership.

Responsibilities

• Develop and maintain the pharmaceutical quality system and governance.
• Provide independent QA oversight of external manufacturing, testing, packaging, labeling.
• Serve as final quality authority for batch disposition and release.
• Review and approve batch records, results, deviations, CAPAs, specs, and validation docs.
• Oversee changes, tech transfers, product introductions, and post‑approval changes.
• Manage CDMOs, contract labs, packagers, distributors; qualify partners.
• Lead regulatory inspection readiness and responses.
• Ensure data integrity and compliant electronic records.
• Lead critical quality events: investigations, recalls, and notifications.
• Develop QA budget and build a high-performing QA organization.

Skills

Quality leadership

GxP knowledge

Regulatory interactions

Risk-based decision making

Executive presence

Cross-functional leadership

Budget management

Education

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

Advanced degree preferred

Job description

Veloxis Pharmaceuticals, Inc. in Cary, NC, seeks a Vice President, Quality Affairs to establish and maintain the company’s global pharmaceutical quality system and provide independent quality oversight across its product portfolio and external GxP network.

This role operates within a fully outsourced model and requires executive leadership for batch disposition, partner governance, regulatory inspections, data integrity, and risk-based quality decisions that protect patients and ensure