Senior Site Quality Director Sterile Injectables

Nexus Search; United States; Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

Nexus Search partners with a major pharma manufacturer to appoint two Site Quality Heads for sterile injectable manufacturing sites in the US. Each role is the most senior quality leader on site, responsible for QA, QC and Quality Systems, leading FDA readiness and remediation, and embedding a quality culture to support growth.

The positions require proven sterile/aseptic quality leadership, extensive FDA inspection experience, and deep knowledge of cGMP, ISO 14644, contamination control, and

Qualifications

• Experience leading QA/QC at a sterile site.
• FDA inspections experience and close-out of 483/Warning Letters.

Responsabilités

• Own QA, QC, Microbiology, Validation support and Training.
• Lead FDA inspections and customer audits.
• Remediate and improve quality systems; manage CAPAs and deviations.
• Set aseptic practice standards and environmental monitoring.
• Own batch disposition authority.
• Drive supplier and materials quality.
• Build quality leadership bench and culture.
• Report to Site Head with dotted line to Global Head of Quality.

Connaissances

Quality leadership

Aseptic manufacturing

cGMP knowledge

Regulatory inspections

Description du poste

Nexus Search partners with a major pharma manufacturer to appoint two Site Quality Heads for sterile injectable manufacturing sites in the US. Each role is the most senior quality leader on site, responsible for QA, QC and Quality Systems, leading FDA readiness and remediation, and embedding a quality culture to support growth.

The positions require proven sterile/aseptic quality leadership, extensive FDA inspection experience, and deep knowledge of cGMP, ISO 14644, contamination control, and