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Supplier Quality Manager / Program Manager with Pharmaceutical exp.

Bannockburn, IL · Biotech/Pharmaceutical
We are seeking a team of experienced Supplier Quality Managers to join the SQA team. This specific role requires experience in Supplier Quality Management plus Program Management experience.   

Responsibilities:
To lead the effort to implement SQM and to support the Supplier Quality function within the department, responsible for delivering all aspects of the Supplier Quality Management global functions:
  • Supplier qualification and specification development processes that use risk-based tools for qualification, classification and performance monitoring
  • Plan, manage and support the conduct of supplier audits
  • Manage existing suppliers in terms of periodic assessments and Quality Agreement maintenance
  • Lead supplier related investigations as necessary
  • 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 in biological sciences or related field with minimum of 10 years experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred
  • Program Management experience is required.
  • Experience 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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