View all jobs

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.   

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
  • 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%)
Powered by