Supplier Quality, QMS and Compliance Expert e/v/e/r/y/o/n/e

The role is responsible for leading Supplier Quality Management and selected Quality Systems and Compliance activities across the assigned areas of responsibility. The position ensures effective qualification, oversight, and lifecycle management of suppliers, contractors, and service providers, while also supporting the maintenance and continuous improvement of the pharmaceutical quality management system. The role acts as a key contact for internal stakeholders and external partners on supplier quality, compliance, and QMS related matters and helps ensure that supplier controls and internal quality processes remain inspection-ready, risk-based, and aligned with applicable regulatory requirements and business needs.
 
Your role will include,

• Direct Supplier Quality Management activities, establishing functional objectives and performance metrics to drive continuous improvement aligned with organizational goals.
• Oversee end-to-end supplier qualification and onboarding through rigorous due diligence, risk assessments, and periodic evaluations to ensure only approved partners are used for GxP activities.
• Lead supplier audits, remote assessments, and qualification visits, driving the timely resolution of audit observations and CAPAs.
• Negotiate, author, and lifecycle-manage robust Quality Agreements with suppliers, contract labs, and service providers to clearly define GMP responsibilities.
• Monitor supplier performance, quality events, change notifications, and compliance trends, ensuring immediate escalation and remediation of risks.
• Support and continuously improve core Pharmaceutical Quality Management System (QMS) processes, including deviations, CAPAs, change controls, and document management.
• Ensure all outsourced activities strictly adhere to cGMP standards, EudraLex Volume 4, ICH guidelines, and emerging industry expectations.
• Maintain constant inspection readiness by overseeing supplier controls and managing the preparation, execution, and follow-up of regulatory inspections and customer audits.
• Partner closely with Procurement, Operations, QC, Validation, and Regulatory affairs to integrate and enforce quality requirements across all business functions.
• Serve as the primary point of contact and advisor for management, internal stakeholders, and external partners on all supplier quality and compliance-related matters