Digital Quality Systems Manager – GMP/GxP Compliance

CSL Vifor; Thatcham; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

CSL Vifor is seeking a Quality Systems professional to support GMP-compliant quality systems across validation, calibration and document management. You will contribute to internal audits and continuous improvement programs while ensuring alignment with FDA/EMA requirements.

The role involves collaboration with project teams and serving as a subject matter expert for computerized systems during health authority inspections. A engineering or scientific degree with 5+ years in cGMP is preferred.

Qualifications

• Bachelor degree in Engineering or a relevant scientific discipline or equivalent experience.
• 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment.
• Knowledge of current Good Manufacturing Practices (cGMP).
• Knowledge of FDA and EMA requirements.

Responsibilities

• Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines.
• Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs).
• Participates in project teams to provide review and approval of project Validationdocumentation according to applicable approval matrix or procedures.
• Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management.
• Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained.
• Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects.
• Supports GxP health authority inspections by serving as subject matter expert forcomputerized systems topics.
• Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems.
• Collaborates to resolve technical issues, provide quality training and communicate best practices.

Skills

Quality systems

GxP compliance

Regulatory guidelines

Audits

Validation

cGMP

Education

Bachelor degree in Engineering or relevant scientific discipline

Tools

LIMS

Document Management System

CAPA system

Change Control system

Validation documentation

Job description

CSL Vifor is seeking a Quality Systems professional to support GMP-compliant quality systems across validation, calibration and document management. You will contribute to internal audits and continuous improvement programs while ensuring alignment with FDA/EMA requirements.

The role involves collaboration with project teams and serving as a subject matter expert for computerized systems during health authority inspections. A engineering or scientific degree with 5+ years in cGMP is preferred.