Vice President, Quality Assurance

About the role

The Vice President, Quality Assurance leads the global pharmaceutical quality system for Veloxis Pharmaceuticals, ensuring clinical and commercial activities meet all regulatory and company standards while supporting strategic objectives.

Key responsibilities

• Lead development, implementation, governance, and continuous improvement of the 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 final quality authority for batch disposition and release, ensuring compliance with market‑specific requirements and Qualified Person certification where required.
• Establish and maintain risk‑based lifecycle programs for qualifying, auditing, and re‑qualifying CDMOs, contract laboratories, packagers, distributors and other GxP suppliers.
• Lead regulatory inspection readiness and act as primary quality representative during inspections and health‑authority interactions.

Required profile

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology or related discipline; advanced degree preferred.
• Minimum 15 years of progressive quality experience in pharmaceutical or biotechnology industry with senior leadership responsibility for commercial products.
• Proven experience leading quality in a fully outsourced model overseeing CDMOs, contract labs, packaging, labeling and distribution partners.
• Broad knowledge of global GMP and GDP regulations including 21 CFR Parts 210/211, EU GMP, ICH guidelines and FDA/EMA expectations.
• Demonstrated ability to make independent, risk‑based product‑quality decisions and to communicate complex quality risks to senior leadership and regulators.

Required skills

• Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance.
• Regulatory knowledge of 21 CFR Parts 210 and 211, EU GMP regulations, ICH guidelines.
• Batch disposition, investigations, change control, CAPA management, and validation oversight.
• Supplier quality oversight, audit of CDMOs and contract laboratories.
• Data integrity, electronic records, and computerized system validation.

What we offer

• Base salary range $320,000 – $350,000 per year.
• Health and insurance benefits.
• Training and professional development opportunities.
• Performance‑based bonus eligibility.