Remote Pharma QA Senior Manager: Validation & Compliance

Jobgether; United States; A distancia; USD 150.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work within United States

Healthcare coverage

Retirement plans

Paid time off

Descripción de la vacante

Jobgether, listed on behalf of a partner, seeks a Senior Manager, Quality Assurance based in the United States to oversee QA for transport validation and packaging validation at CMOs, ensuring GMP compliance and launch readiness.

You will lead deviations, CAPAs, change controls, document control, and improve quality systems while collaborating with cross-functional teams to meet regulatory requirements.

Formación

• Bachelor's degree in a scientific or technical field.
• 8+ years in pharmaceutical QA with validation and CMOs.
• Strong knowledge of GMP regulations and quality management systems (QMS).
• Experience overseeing deviations, CAPAs, change controls, and document control.

Responsabilidades

• Lead QA oversight of transport validation and packaging validation at CMOs.
• Represent QA in cross-functional teams on quality, compliance, and regulatory expectations.
• Act as SME for deviations, CAPAs, change controls, and controlled documentation revisions.
• Review and approve manufacturing, packaging, labeling, and validation documentation.
• Oversee quality aspects of validation, packaging, and testing with external partners.
• Establish and report quality metrics, risks, and compliance issues to senior management.
• Update and improve GMP SOPs and quality procedures.

Conocimientos

Quality assurance

Educación

Bachelor's degree in a scientific or technical discipline

Descripción del empleo

Jobgether, listed on behalf of a partner, seeks a Senior Manager, Quality Assurance based in the United States to oversee QA for transport validation and packaging validation at CMOs, ensuring GMP compliance and launch readiness.

You will lead deviations, CAPAs, change controls, document control, and improve quality systems while collaborating with cross-functional teams to meet regulatory requirements.