QA & Compliance Leader — GDP, FDA, On-Site

Sotalent; Minnesota; Presencial; USD 76.000 - 119.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical benefits

Dental benefits

Vision benefits

Parental leave

Mentorship programs

Descripción de la vacante

Sotalent is seeking an experienced Quality Assurance Manager to oversee quality management, regulatory compliance, and health and safety operations in a pharmaceutical and animal health distribution facility. The role ensures the Quality Management System (QMS) remains effective and GDP compliance across distribution operations.

The position involves collaboration with site leadership, regulatory authorities, and operational teams to maintain compliance, drive process improvements, and foster a

Formación

• Bachelor's degree in life sciences, business administration, or related field.
• Minimum 4 years of progressively responsible experience in quality assurance or regulatory compliance.
• Strong knowledge of GDP and pharmaceutical distribution processes.
• Familiarity with FDA, DEA, EPA, OSHA and state regulatory requirements.

Responsabilidades

• Manage and maintain the facility's Quality Management System (QMS) and GDP.
• Ensure compliance with FDA, DEA, EPA, OSHA and state regulations.
• Oversee regulatory licensing, registrations, inspections, and compliance documentation.
• Act as the primary contact for regulatory agencies and support inspections.
• Conduct quality, safety, and regulatory assessments.
• Implement CAPA, root cause analysis, and risk management processes.
• Maintain compliance with pharmaceutical storage, transportation, and distribution standards, including USP 1079.

Conocimientos

Quality management

Regulatory compliance

Leadership

Regulatory inspections

Educación

Bachelor's degree in Life Sciences, Business Admin., or related field

Descripción del empleo

Sotalent is seeking an experienced Quality Assurance Manager to oversee quality management, regulatory compliance, and health and safety operations in a pharmaceutical and animal health distribution facility. The role ensures the Quality Management System (QMS) remains effective and GDP compliance across distribution operations.

The position involves collaboration with site leadership, regulatory authorities, and operational teams to maintain compliance, drive process improvements, and foster a