Sr. Specialist, Supplier Quality Management (EMEA)

Reporting to the Manager, Supplier Quality Management (EMEA), this role is responsible for the quality oversight of suppliers across the EMEA region. The successful candidate will manage supplier quality activities throughout the supplier lifecycle, including qualification, quality risk management, change control, and issue resolution. Using a risk-based approach, the role supports compliance with GxP requirements, company standards, and regulatory expectations while working collaboratively with suppliers and cross-functional stakeholders to ensure product quality, regulatory compliance, and continuity of supply.

Key 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.

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.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.