Lead & Develop the Team: Guide a group of supplier quality specialists by setting expectations, coaching regularly, and encouraging a culture focused on improvement and compliance.
Supplier Oversight: Create and manage processes for bringing new suppliers on board, evaluating risks, performing audits, and tracking ongoing performance for materials, components, and outsourced services.
Quality System Management: Oversee the systems that support supplier quality, including vendor approval workflows, inspection requirements for incoming goods, and performance scorecards aligned with regulated-industry standards.
Regulatory Alignment: Make sure all supplier-related quality activities meet global health authority expectations and are carried out in accordance with applicable guidelines.
Audit Execution: Coordinate and perform supplier auditsfrom initial qualification to routine reviews and investigationswhile ensuring findings are well documented and followed by effective corrective actions.
Process Optimization: Spot opportunities to streamline processes, reduce delays, and support operational growth while strengthening compliance.
Cross-Functional Support: Work closely with procurement, manufacturing, labs, and regulatory teams to embed supplier quality needs into overall business processes.
Risk & Supply Continuity: Assess supplier risks, create mitigation plans, and respond to supply?chain issues to minimize disruption to production activities.
Reporting & Documentation: Keep thorough records, track supplier performance, prepare summaries for leadership, and support documentation needs during regulatory reviews.
Change Review: Assess and approve proposed changes from suppliers, ensuring risks are evaluated and testing or regulatory notifications happen when required.
Training & Expertise: Build and deliver training related to supplier quality expectations and maintain up-to-date knowledge of evolving regulations.
Bachelors degree in a scientific, engineering, or related field.
At least seven years of experience in pharmaceutical quality roles, including three years specifically in supplier quality oversight.
Strong understanding of regulations and guidelines relevant to quality systems and pharmaceutical manufacturing.
Experience evaluating, qualifying, and routinely monitoring suppliers.
Proven ability to enhance quality processes and lead improvement initiatives.
Strong communication skills and the ability to work effectively with both suppliers and internal teams.
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