Senior Manager, External Quality & Process Excellence

6010-Biosense Webster Inc. Legal Entity; Borgo San Michele; Presencial; EUR 71 000 - 123 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being programs

Resumo da oferta

Johnson & Johnson is seeking a Senior Manager, External Quality Business Processes and Strategic Projects to lead EQ process improvements and strategic initiatives ensuring compliant and efficient execution.

The role focuses on establishing a Lean culture, leading data integrity governance, and cross-functional collaboration across platforms and sites. Travel up to 10% may be required.

Qualificações

• University/Bachelor’s degree in sciences required; Master’s degree preferred.
• 10+ years of experience in Quality Assurance, Quality Control, Validation or Engineering in pharmaceutical industry.
• 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 awareness preferred.
• Proven project management skills; Lean/Six Sigma certification preferred.

Responsabilidades

• Establish Lean culture within External Quality (EQ) using Lean, Value Stream Mapping to identify and deliver improvements.
• Owns and executes Root Cause Problem Solving to investigate and resolve issues.
• Facilitates complex investigations using advanced techniques (e.g., Kepner-Trego) and applies statistical analysis.
• Acts as EQ Data Integrity/Governance SPOC with cross-platform teams to support risk-based planning and remediation.
• Ensures knowledge management framework and cross-functional alignment across platforms.
• Represents EQ with Change Champion efforts to standardize processes and adopt SAP S/4HANA.
• Manages cross-functional risks and resources, defines KPIs, and drives QMR projects.
• Owns communication and change management across platforms; supports FDA BPDR submissions.

Conhecimentos

Quality Assurance

Project Management

Data Integrity

Regulatory Compliance

GMP Standards

Six Sigma

Budget Management

Leadership

Communication

Formação académica

Bachelor’s degree in sciences

Master’s degree preferred

Descrição da oferta de emprego

Johnson & Johnson is seeking a Senior Manager, External Quality Business Processes and Strategic Projects to lead EQ process improvements and strategic initiatives ensuring compliant and efficient execution.

The role focuses on establishing a Lean culture, leading data integrity governance, and cross-functional collaboration across platforms and sites. Travel up to 10% may be required.