Manager, Quality Management System, Supplier Quality

Jobtailor; Deutschland; Remote; EUR 75.000 - 110.000; Vollzeit

Zusammenfassung

CellCarta is seeking a Quality Management lead to sustain and harmonize the QMS across the organization, including supplier quality programs and audits.

The role focuses on data-driven quality improvements, policy development, and collaboration with cross-functional teams to ensure compliance with ISO13485, ISO15189, GCLP, and CAP/CLIA requirements.

Qualifikationen

• Minimum bachelor’s degree in life sciences, applied sciences, business, or related field.
• Minimum of 5 years' industry or related experience.
• 2 years of audit experience.
• Knowledge and experience with supplier quality systems.
• Knowledge of GCLP and GMP requirements.
• Knowledge of ISO13485 and ISO15189 frameworks and CAP/CLIA requirements.
• Experience interfacing with suppliers and aligning on a quality agreement framework.
• Knowledge of compliance requirements for different stages of development and applicable global regulations.
• Proficiency in French and English, spoken and written.
• Demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity.
• Excellent project management skills.
• Ability to merge business and compliance needs to achieve effective solutions.

Aufgaben

• Lead and support the development and sustainability of CellCarta's Quality Management System (QMS).
• Harmonize quality procedures and processes.
• Provide quality data for the Corporate Quality Management Review.
• Develop and improve harmonized policies, procedures, and work instructions.
• Establish reports to gather and analyze quality data.
• Coordinate document control, including revisions, training assignments, and issuance of corporate procedures and policies.
• Support the Supplier Quality Program by classifying and qualifying suppliers.
• Audit suppliers and maintain quality agreements with corporate suppliers.
• Serve as the primary interface with corporate suppliers.
• Maintain the Supplier Corrective Action Request (SCAR) system, global approved supplier list, and audit schedule.
• Develop and execute an IT third-party vendor management program.
• Support software development projects throughout the software development lifecycle, including planning, requirements, risk management, design, verification, validation, release, and change management.
• Participate in ISO certification audits, including ISO-27001 and ISO13485 audits.
• Serve as a subject matter expert on Quality Management Systems.
• Support proposal development while collaborating with cross-functional professionals.

Kenntnisse

Quality Management Systems

Supplier Quality Program Management

ISO13485 and ISO15189 Knowledge

Project Management Skills

Bilingual French & English

Written and Verbal Communication

Compliance and Regulatory Knowledge

Quality Data Analysis

Ausbildung

Bachelor's degree in life sciences or related field

Jobbeschreibung

• Lead and support the development and sustainability of CellCarta's Quality Management System (QMS)
• Harmonize quality procedures and processes
• Provide quality data for the Corporate Quality Management Review
• Develop and improve harmonized policies, procedures, and work instructions
• Establish reports to gather and analyze quality data
• Coordinate document control, including revisions, training assignments, and issuance of corporate procedures and policies
• Support the Supplier Quality Program by classifying and qualifying suppliers
• Audit suppliers and maintain quality agreements with corporate suppliers
• Serve as the primary interface with corporate suppliers
• Maintain the Supplier Corrective Action Request (SCAR) system, global approved supplier list, and audit schedule
• Develop and execute an IT third-party vendor management program
• Support software development projects throughout the software development lifecycle, including planning, requirements, risk management, design, verification, validation, release, and change management
• Participate in ISO certification audits, including ISO-27001 and ISO13485 audits
• Serve as a subject matter expert on Quality Management Systems
• Support proposal development while collaborating with cross-functional professionals

Requirements

• Minimum bachelor’s degree in life sciences, applied sciences, business, or related field
• Minimum of 5 years' industry or related experience
• 2 years of audit experience
• Knowledge and experience with supplier quality systems
• Knowledge of GCLP and GMP requirements
• Knowledge of ISO13485 and ISO15189 frameworks and CAP/CLIA requirements
• Experience interfacing with suppliers and aligning on a quality agreement framework
• Knowledge of compliance requirements for different stages of development and applicable global regulations
• Proficiency in French and English, spoken and written
• Demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity
• Excellent project management skills
• Ability to merge business and compliance needs to achieve effective solutions

Core Competencies

Demonstrates expertise in Quality Management Systems, including ISO13485 and ISO15189 frameworks, while effectively managing supplier quality programs and compliance with GCLP and GMP requirements. Proficient in project management and communication, ensuring alignment between business and compliance needs.

Highest-signal resume keywords

• Quality Management System Development
• Supplier Quality Program Management
• ISO13485 and ISO15189 Knowledge
• Project Management Skills
• Bilingual Proficiency in French and English

ATS Optimization Keywords

Hard Skills

• Quality Data Analysis
• Document Control Coordination
• Supplier Auditing
• SCAR System Maintenance
• IT Vendor Management
• Software Development Lifecycle Support
• Risk Management
• Policy Development
• Compliance Requirements Knowledge
• Quality Agreement Framework Alignment

Soft Skills

• Written Communication Skills
• Verbal Communication Skills
• Collaboration with Cross-Functional Teams
• Ability to Articulate Complex Agreements
• Problem-Solving Skills

Industry Keywords

• GCLP
• GMP
• CAP/CLIA
• Supplier Quality Systems
• Corporate Quality Management Review
• Audit Experience
• Quality Procedures Harmonization
• Quality Agreements
• ISO Certification Audits
• Life Sciences