Senior Manager, Quality Process Excellence & Strategy

Biopharma Asia; Zug; Teletrabalho; CHF 140 000 - 210 000; Tempo integral

Resumo da oferta

Biopharma Asia seeks a Senior Manager for External Quality Business Processes and Strategic Projects to lead process improvements and governance across EQ. You will drive Lean initiatives, establish data integrity frameworks, and coordinate cross-functional global teams to standardize processes and support system implementations.

Requires a strong background in GMP-regulated pharma environments, RCM, and project leadership with a focus on patient safety and quality.

Qualificações

• University/Bachelor’s degree in sciences required; Master’s degree preferred.
• 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.
• Proven knowledge of applicable Data Integrity regulations.
• Experience in FDA/EMA GMP-regulated environments and familiarity with ISO requirements.

Responsabilidades

• Establish a Process Excellence/Lean culture within EQ using methodologies like Lean, Value Stream Mapping to identify and deliver improvements.
• Owns and executes the Root Cause Problem Solving process to investigate issues.
• Facilitates complex investigations using advanced methods and applies statistical analysis to data sets.
• Acts as EQ Data Integrity/Governance SPOC: design and implement the framework and drive gap remediation across platforms.
• Ensures cross-functional alignment and risk-based resource planning.
• Defines and collects KPIs to support platform metrics and project portfolios.
• Owns communications and change management across platforms and supports S/4 HANA adoption.

Conhecimentos

BPM

Compliance

Data Integrity

Cross-Functional Collaboration

Fact-Based Decision Making

Stakeholder Engagement

Lead Projects

Formação académica

Bachelor’s degree in sciences

Master’s degree preferred

Ferramentas

ISO 9001

GMP

Descrição da oferta de emprego

Biopharma Asia seeks a Senior Manager for External Quality Business Processes and Strategic Projects to lead process improvements and governance across EQ. You will drive Lean initiatives, establish data integrity frameworks, and coordinate cross-functional global teams to standardize processes and support system implementations.

Requires a strong background in GMP-regulated pharma environments, RCM, and project leadership with a focus on patient safety and quality.