Hybrid VP, Global Quality & Compliance - Pharma

Pharmaceutical Compliance Forum Inc; Cary, Northern (NC, KY); Hybride; USD 320 000 - 350 000; Plein temps

Résumé du poste

Veloxis Pharmaceuticals, Inc., an Asahi-Kasei Group Company based in Cary, NC, seeks a Vice President, Quality Affairs to establish and lead the global pharmaceutical quality system with external GxP oversight. This executive role ensures compliance across clinical and commercial activities and guides product disposition and inspections.

Responsibilities include risk-based review of records, management of external partners, regulatory inspections readiness, data integrity oversight, and building

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 15+ years of progressive quality experience in pharma/biotech with leadership.
• Experience leading quality in outsourced models with CDMOs and partners.
• Broad modality exposure: solid dosage, biologics, or oligonucleotides.

Responsabilités

• Lead development and governance of the pharmaceutical quality system and QMS.
• Provide independent quality oversight of clinical and commercial manufacturing and testing by external partners.
• Serve as final quality authority for batch disposition and release within delegated scope.
• Oversee inspections readiness and responses, and manage governance with external partners.
• Establish risk-based lifecycle for CDMOs, contract labs, packagers, and distributors.
• Monitor quality performance metrics and escalate significant risks.

Connaissances

Quality leadership

Regulatory affairs

GxP oversight

Executive communication

risk management

Budget management

Supplier quality

Auditing & inspections

Cross-functional leadership

Formation

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

Outils

GxP systems

Description du poste

Veloxis Pharmaceuticals, Inc., an Asahi-Kasei Group Company based in Cary, NC, seeks a Vice President, Quality Affairs to establish and lead the global pharmaceutical quality system with external GxP oversight. This executive role ensures compliance across clinical and commercial activities and guides product disposition and inspections.

Responsibilities include risk-based review of records, management of external partners, regulatory inspections readiness, data integrity oversight, and building