Senior Quality Systems Lead, Global Readiness

GRIFOLS, S.A.; Clayton (NC); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Grifols is seeking a Sr. Quality Systems Specialist for Quality Operational Readiness (QOR) to support the implementation of quality systems at new Biopharma facilities across global locations and ensure regulatory compliance from inception.

The role requires collaboration with Engineering, Manufacturing, Regulatory Affairs, IT and Global Quality to embed robust quality processes. The position emphasizes independent execution, proactive problem-solving, and effective stakeholder management, with

Formación

• PhD or MS/BS with years of relevant experience as specified.
• Experience with cGMP regulatory expectations and global health authority knowledge.
• Travel up to 15–50% to Biopharma sites worldwide.

Responsabilidades

• Support implementation and readiness of Quality functions at new Biopharma facilities across global locations.
• Collaborate with cross-functional teams to embed quality in design and operations for new start-up processes.
• Translate objectives into practical deliverables and plans with minimal oversight.
• Execute Operational Readiness deliverables with independence, ownership, and accountability.
• Monitor timelines, KPIs, and risk mitigation for site readiness and regulatory inspections.

Conocimientos

Analytical Thinking

Communication

Independent Execution

Risk Management

Problem-Solving

Regulatory Knowledge Management

Collaboration

Project Management

Learning Agility

Educación

PhD in Life Sciences

MS in Life Sciences

BS in Life Sciences

Descripción del empleo

Grifols is seeking a Sr. Quality Systems Specialist for Quality Operational Readiness (QOR) to support the implementation of quality systems at new Biopharma facilities across global locations and ensure regulatory compliance from inception.

The role requires collaboration with Engineering, Manufacturing, Regulatory Affairs, IT and Global Quality to embed robust quality processes. The position emphasizes independent execution, proactive problem-solving, and effective stakeholder management, with