Engineering Compliance Management Lead

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

• Define and drive the Engineering Compliance framework standards and approach across Global Engineering.

• Act as central interface between Global Engineering andGlobalQuality serving as the Engineering Compliance SME by translating enterprise compliance frameworks and standards defined by Global Quality into practical Engineering implementation and execution.

• Ensure visibility consistency and structured handling of Engineering compliance topics (e.g. findings KPIs inspection readiness).

• Drive continuous improvement harmonization and digitalization of Engineering Compliance including data-driven approaches.

How you will contribute:

Engineering Compliance Framework & Governance

• Definemaintain and continuously improve the Engineering Compliance framework standards and processes across Global Engineering.

• Ensure alignment withGxPand regulatory expectations and translate them into Engineering-specific requirements and guidance.

• Interpret and operationalize enterprise compliance frameworks and standards defined by Global Quality within Engineering.

Compliance Oversight Transparency & Risk Management

• Ensure global visibility and transparency of Eng.compliance topics (KPIs inspectionfindings).

• Establish andmaintainstructured tracking and reporting of compliance topics acrossGE.

• Identifytrends systemic gaps risks and proactively drive mitigation and improvement actions.

• Support inspection readiness by ensuring Engineering-related compliance risks areidentifiedand addressed.

• Contribute to and activelyparticipatein the Community of Excellence (CoE) for Global Engineering departments.

Global Coordination & Site Interface

• Act ascentralinterface for Eng Compliance topics betweenGE Quality and sites.

• Drive implementation of Eng Compliance initiatives and ensure consistent application.

• Support site preparation for inspections and audits in collaboration with CQV Leads.

• Provide guidance and direction to CQV Leads for implementation and execution at site level.

Integration with CQV & Lifecycle Activities

• Ensure and enable implementation of Eng Compliance initiatives across sites through CQV Leads.

• Collaborate closely with CQV Leads and Global Quality to ensure consistent and compliant implementation.

Continuous Improvement & Compliance Excellence

• Provide technical SME input and feedback to Global Quality to supportcontinuousimprovementof enterprise compliance frameworks and standards.

• Drive continuous improvement and harmonization of Engineering Compliance processes.

• Lead global initiatives to improve consistency efficiency and compliance performance.

• Analysecompliance data trends and inspection outcomes to derive improvement measures.

• Promote best practices and ensure knowledge sharing across Engineering.

• Quality Eng and site functions to ensurealignedandinspection-ready.

What you bring to Takeda:

• Degree in engineering or pharmaceutical science or equivalent

• Languages: Business fluentproficiencyin English

• Experience: 10 years in a GMP-regulated environment (Engineering CQV or Quality)

• Strong knowledge ofGxPand Engineering Compliance topics

• Strong analytical mindset and problem-solving skills

• High communication skills ability to influence across functions

• Strong collaboration and stakeholder management skills

Preferred

• Experience in CQVorvalidationlifecycle

• Experience in multi-siteorglobalroles

Locations

Zurich Switzerland

Base Salary Range:

CHF159300.00 - CHF219010.00

For information about our benefits please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1