Executive, Global Quality Assurance

Bionova Scientific LLC; Cary (NC); Hybrid; USD 320,000 - 350,000; Full time

Job summary

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

The role is performed within a fully outsourced model, with authority to reject products, suspend activities, and oversee inspections. Base compensation ranges from $320k to $350k, depending on experience and market conditions.

Qualifications

• Bachelor’s degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or related field.
• At least 15 years of progressively responsible quality experience in pharma/biotech with leadership responsibility for commercial products.
• Experience leading quality in outsourced models with oversight of CDMOs, contract labs, packaging/labeling providers, distributors and other GxP suppliers.
• Broad experience across product modalities; experience with two of oral solids, biologics, or oligonucleotides preferred.
• Extensive knowledge of GMP/GDP requirements and regulatory expectations; interaction with regulatory authorities and inspections.

Responsibilities

• Develop, implement, govern, and improve the company’s pharmaceutical quality system and QMS governance.
• Provide independent Quality oversight of clinical and commercial manufacturing, testing, packaging, labeling, storage, and distribution with external partners.
• Serve as final Quality authority for batch disposition and release within delegated responsibilities; ensure compliance with market-specific requirements.
• Oversee batch records, analytical results, deviations, investigations, change controls, CAPAs, specifications, validation docs, and records affecting product quality.
• Provide QA oversight of process/analytical changes, tech transfers, validations, new products, acquisitions, and post-approval changes.
• Establish lifecycle program for qualifying and monitoring CDMOs, contract labs, packagers, distributors, and other GxP suppliers.
• Establish quality agreements with external partners and governance processes; define responsibilities and escalation pathways.
• Monitor quality performance via metrics, trend analysis, and governance; escalate significant risks.
• Lead regulatory inspection readiness and serve as QA representative during inspections and responses.
• Oversee data integrity, electronic records, and computerized systems within the company and external network.
• Support critical quality events and due diligence activities as applicable.

Skills

Quality Leadership

Regulatory Compliance

GxP Oversight

Risk Assessment

Executive Communication

Education

Bachelor’s degree in a science/engineering field

Advanced degree preferred

Job description

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

The role is performed within a fully outsourced model, with authority to reject products, suspend activities, and oversee inspections. Base compensation ranges from $320k to $350k, depending on experience and market conditions.