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Supplier Quality Manager

Durham, North Carolina · Biotech/Pharmaceutical
We are seeking an experienced Supplier Quality Management professional to join us and contribute to our SQA operations as we continue to develop and maintain supplier quality standards to ensure company products are manufactured to relevant patient safety and product quality standards in line with business requirements.  (Must have experience with Supplier Quality Assurance).
 
Responsibilities:
To support the Supplier Quality function within the department, responsible for delivering all aspects of the Supplier Quality Management global functions:
  • Focal point for managing supplier quality related issues and supplier-related change notifications; Facilitate the escalation of unresolved supplier/material quality issues within assigned projects and suppliers
  • Plan, manage and support the conduct of supplier audits
  • Manage existing suppliers in terms of periodic assessments and Quality Agreement maintenance
  • Perform transactions for Supplier-related records and maintain data synchronization between suppliers and materials in various internal data systems
  • Provide clear communication (both verbally and orally) to all levels within the organization on quality related topics
  • Effectively evaluate materials, components, and services provided by suppliers in terms of quality, regulatory, and business risk.
  • Undertake root cause analyses and identify solutions for supply chain issues. Ensure corrective and preventive actions are closed out by suppliers
  • Work with the Purchasing team on new supplier introduction and approval
  • Work within the cross-functional team to define criteria to ensure supplier process capability is effective to meet product and process requirements measure key supplier quality performance
  • Support the Associate Director of the department to monitor and report on supplier product quality and performance
 
Requirements:
  • Bachelor’s Degree required in a scientific discipline
  • 6+ years of overall working experience in Biotech/Pharmaceutical industry, with at least 3 years of directly supporting the Supplier Quality Assurance functions is required
  • Understanding of common biologics and sterile chemical materials manufacturing processes is strongly preferred
  • Hands on knowledge of quality management and business systems for managing suppliers and materials is required
  • Strong Knowledge of GMP (US, EU and APAC) as well as ISO standards with regards to material and service providers
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
  • Ability to work in a diverse and dynamic environment
  • Willingness to think outside of the box and adapt best practices to the growing environment
  • Good communication and interpersonal skills
  • Certification in PMP, CQA or ASQ is highly desired
  • Ability to Travel (10%)
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