Supplier Quality Assurance Manager

Job Responsibilities

• 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 audits—from initial qualification to routine reviews and investigations—while 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.

• Bachelor’s 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.