Senior Manager, External Quality & Process Excellence

Biopharma Asia; Dublin; Presencial; EUR 86.000 - 148.000; Jornada completa

Descripción de la vacante

Johnson & Johnson seeks a Senior Manager, External Quality Business Processes and Strategic Projects to drive process improvements across External Quality (EQ). You will lead initiatives using Lean and Six Sigma, manage root cause analysis, and champion data integrity governance across platforms.

Collaboration with global teams and change management are key aspects of this role. The role involves guiding cross-functional teams, implementing KPI-driven improvements, and ensuring regulatory

Formación

• University/Bachelor’s degree in sciences required; Master’s degree preferred.
• 10+ years in Quality Assurance, Quality Control, Validation or Engineering in pharma.
• Experience with quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review.
• FDA/EMA GMP-regulated environment experience; ISO knowledge preferred.

Responsabilidades

• Establishes a Process Excellence/Lean culture within EQ and delivers improvements.
• Owns and executes Root Cause Problem Solving to investigate and solve issues.
• Facilitates complex investigations using advanced techniques and applies statistics to data sets.
• Acts as EQ Data Integrity/Governance SPOC with platform teams to support risk-based planning.
• Defines KPIs to support platform metrics and QMR for projects.
• Owns communication and change management across platforms for specific projects.

Conocimientos

Quality Assurance

Quality Control

Validation

Project management

Lean / Six Sigma

Educación

Bachelor's degree in sciences

Master's degree preferred

Herramientas

Kepner-Tregoe

Value Stream Mapping

Lean

Six Sigma

S/4 HANA

Descripción del empleo

Johnson & Johnson seeks a Senior Manager, External Quality Business Processes and Strategic Projects to drive process improvements across External Quality (EQ). You will lead initiatives using Lean and Six Sigma, manage root cause analysis, and champion data integrity governance across platforms.

Collaboration with global teams and change management are key aspects of this role. The role involves guiding cross-functional teams, implementing KPI-driven improvements, and ensuring regulatory