Associate Director, QA – GMP & Validation (Remote)

Travere Therapeutics; Denver (CO); Híbrido; USD 150.000 - 195.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Premium health benefits

Hybrid/Remote-friendly environment

Descripción de la vacante

The role leads validation activities, change control, deviations, CAPA and risk management, working with Technical Operations to ensure compliance with CFR/ICH and internal standards. 8+ years in GMP QA and a Life Sciences degree are required, Master’s preferred. Travel 10-25%.

Formación

• 8+ years of direct experience in GMP Quality Assurance or Quality Systems in biotech/pharma.
• Strong knowledge of CFR/ICH rules and international regulations.
• Excellent verbal and written communication, with leadership experience.

Responsabilidades

• Provide QA/GxP guidance for GMP CSPs from drug substance to commercialization.
• Oversee validation activities including VMPs, VP, URS, PV protocols/reports.
• Handle change control, deviations, CAPAs, OOS/OOT investigations, risk management, and vendor qualification.
• Collaborate with Technical Operations to approve CSP documentation and ensure regulatory compliance.

Conocimientos

GMP Quality Assurance

Regulatory knowledge

Leadership/People management

Educación

Bachelor's degree in Life Sciences

Master's degree preferred

Descripción del empleo

The role leads validation activities, change control, deviations, CAPA and risk management, working with Technical Operations to ensure compliance with CFR/ICH and internal standards. 8+ years in GMP QA and a Life Sciences degree are required, Master’s preferred. Travel 10-25%.