EMEA Supplier Quality Lead - GxP & Risk Mgmt

CSL Vifor; Liverpool; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

CSL Vifor is seeking a Supplier Quality Manager to oversee supplier quality across the EMEA region. You will manage qualification, risk assessment, change control, and issue resolution to maintain product quality and regulatory compliance.

You will collaborate with Quality, Manufacturing and Regulatory teams to support supplier-related activities and continuous improvement within the program.

Qualifications

• Bachelor's degree in Science, Engineering, Quality, or a related discipline.
• Minimum 3 years' experience in a GxP-regulated environment.
• Experience within the pharmaceutical, biotechnology, vaccine, medical device, or related industries.
• Knowledge of supplier quality management, quality systems, change control, deviations, investigations, CAPA, and quality risk management.
• Understanding of applicable global regulations and GxP requirements.
• Experience reviewing supplier quality documentation and assessing quality and compliance risks.
• Strong analytical, communication, stakeholder management, and problem-solving skills.

Responsibilities

• Manage supplier qualification, onboarding, periodic review, and ongoing oversight activities in accordance with GxP requirements and company standards.
• Review and assess supplier quality documentation, including change notifications, deviations, investigations, CAPAs, regulatory inspection outcomes, and quality metrics.
• Evaluate supplier changes, quality events, and compliance issues using a risk-based approach to determine potential impact on product quality, patient safety, regulatory compliance, and continuity of supply.
• Partner with suppliers and internal stakeholders to investigate and resolve supplier quality issues in a timely manner.
• Establish, review, and maintain Supplier Quality Agreements with suppliers and service providers.
• Collaborate with Quality, Manufacturing, Technical Services, Regulatory Affairs, Procurement, Supply Chain, and other business functions to support supplier-related activities.
• Apply quality risk management principles and sound scientific judgement to support quality decisions and supplier oversight activities.
• Contribute to continuous improvement initiatives within the Supplier Quality Management program.

Skills

Supplier quality management

Quality systems

CAPA & deviations

GxP compliance

Risk management

Regulatory knowledge

Analytical thinking

Communication skills

Stakeholder management

Problem solving

Education

Bachelor's degree in Science/Engineering/Quality

Job description

CSL Vifor is seeking a Supplier Quality Manager to oversee supplier quality across the EMEA region. You will manage qualification, risk assessment, change control, and issue resolution to maintain product quality and regulatory compliance.

You will collaborate with Quality, Manufacturing and Regulatory teams to support supplier-related activities and continuous improvement within the program.