Supplier Quality Management (Consultant - 6 months+)

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. United States
Chicago, USA
Posting date: 17 Oct 2019
QA.WH.25841_1571328969

An internationally leading biotechnology company is seeking a Supplier Quality Management Consultant to their office in the Greater Chicago area. The organization is renowned for their work in gene therapy and challenging life-threatening diseases through their innovative platform. This is an exciting opportunity to work with an organization that prides itself on its cutting-edge scientific approach.

Job Responsibilities:

  • 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 the company's various internal data systems.
  • Manage supplier quality related issues and supplier-related change notifications; Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers.
  • Provide clear communication (both verbally and orally) to all levels within the organization on quality related topics.
  • 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 Sr. Director of the department to monitor and report on supplier product quality and performance.

Skills and Requirements:

  • Bachelor's Degree required in a scientific discipline.
  • 10+ years of overall working experience in Biotech/Pharmaceutical industry, with at least 5 years of directly supporting the Supplier Quality Assurance functions is required.
  • Preferred experience in managing GCP/GPvP suppliers, third party logistics, transportation couriers and cold chain logistics.
  • 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.
  • Certification in PMP, CQA or ASQ is highly desired.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Will Hitchcock at +44 203 078 9554 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-WH1

#Compliance/Quality

close