Senior Manager, External Quality & Process Excellence

Biopharma Asia; Latina; On-site; EUR 71,000 - 123,000; Full time

Job summary

Johnson & Johnson in Italy, Latina, is seeking a Senior Manager, External Quality Business Processes and Strategic Projects. This role drives process excellence across External Quality, leading strategic projects to ensure compliant and efficient execution in a global GMP environment.

You will implement Lean culture, own root cause analysis, manage dashboards and KPIs, and partner with cross-functional teams to standardize processes and support S/4 HANA adoption.

Qualifications

• 10+ years of combined experience in Quality Assurance, Quality Control, Validation or Engineering in the pharmaceutical industry.
• Working knowledge of quality systems such as Risk Management, Investigation/CAPA, Change Control, Document Management and Management Review.
• Experience in FDA/EMA GMP-regulated environment; ISO familiarity preferred.
• Six Sigma and/or Lean certification preferred, or willingness to obtain it.

Responsibilities

• Establish a Process Excellence/Lean culture within EQ.
• Owns Root Cause Problem Solving process and drives improvements.
• Lead complex investigations using Kepner-Tregoe and statistics.
• Act as EQ SPOC for Data Integrity/Governance and drive risk-based plans.
• Define KPIs and manage the EQ project portfolio.

Skills

Lean methodologies

Root Cause Analysis

Data Integrity

Project Management

Quality Systems

Education

Bachelor's degree in sciences or engineering

Master’s degree preferred

Job description

Johnson & Johnson in Italy, Latina, is seeking a Senior Manager, External Quality Business Processes and Strategic Projects. This role drives process excellence across External Quality, leading strategic projects to ensure compliant and efficient execution in a global GMP environment.

You will implement Lean culture, own root cause analysis, manage dashboards and KPIs, and partner with cross-functional teams to standardize processes and support S/4 HANA adoption.