Global Quality Leader: Strategy, Compliance & Growth

ProSciento, Inc.; United States; Híbrido; USD 230.000 - 390.000; Tempo integral

Resumo da vaga

ProSciento, Inc. seeks a Global Head of Quality to set the strategic direction of the Quality department, govern the QMS, and ensure adherence to GxP, FDA, and ISO standards across global operations.

This executive role partners with leadership to drive continuous improvement, risk management, and inspection readiness. Responsibilities include design and governance of quality systems, management of CAPAs and inspections, and development of quality culture while maintaining compliance across CRO

Qualificações

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• Minimum 10 years in Quality/Regulatory within CRO or clinical research; 5+ years in senior leadership; 3+ years global experience.
• Equivalent combinations of education, training, and experience considered.

Responsabilidades

• Provide strategic leadership for the Quality department and set vision/priorities.
• Oversee QMS design, implementation, and continuous improvement in line with GxP and regulatory requirements.
• Lead inspection readiness, CAPA governance, audits, and supplier qualification programs.
• Develop and govern QMS documentation, policies, SOPs, and training programs.
• Foster a culture of quality and partner with executives to drive strategic initiatives.

Conhecimentos

Quality leadership

Regulatory compliance

GxP knowledge

Executive communication

Quality strategy

Risk management

Formação

Bachelor's degree in Life Sciences

Advanced degree preferred

Ferramentas

eQMS

Document management

Descrição da vaga

ProSciento, Inc. seeks a Global Head of Quality to set the strategic direction of the Quality department, govern the QMS, and ensure adherence to GxP, FDA, and ISO standards across global operations.

This executive role partners with leadership to drive continuous improvement, risk management, and inspection readiness. Responsibilities include design and governance of quality systems, management of CAPAs and inspections, and development of quality culture while maintaining compliance across CRO