Senior Specialist, Quality Assurance, Compliance And Supplier Quality
OXB
Durham, NC, US
On-site
Supplier qualification and lifecycle management
Supplier audits and capa assessment
Oversight of critical and single/sole-source suppliers
You will be responsible for providing quality oversight of suppliers and vendors supporting the manufacture, packaging, testing, and distribution of clinical and commercial gene and cell therapy products at OXB
Job Summary
You will be responsible for providing quality oversight of suppliers and vendors supporting the manufacture, packaging, testing, and distribution of clinical and commercial gene and cell therapy products at OXB.
Your responsibilities in this role would be to provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.
We are looking for a Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field with a minimum of 8 years of pharmaceutical industry experience, working in Supplier Quality role, and/or Quality/Compliance Experience in biotechnology industry preferred.
Matching Summary
You will be responsible for providing quality oversight of suppliers and vendors supporting the manufacture, packaging, testing, and distribution of clinical and commercial gene and cell therapy products at OXB.
Skills & Requirements
Must-have
Supplier qualification and lifecycle management
Supplier audits and CAPA assessment
Oversight of critical and single/sole-source suppliers
Supplier change notification management
Supplier deviation and quality event assessment
Nice-to-have
Advancing life-changing therapies
Collaborative and inclusive culture
State-of-the-art facilities
Key Requirements
Bachelor's degree or higher in Life Sciences, Chemistry, Engineering, or related field
Minimum of 8 years of pharmaceutical industry experience
Experience in Supplier Quality role and/or Quality/Compliance
Strong knowledge of cGMP in Pharma/Biotech
Knowledge of aseptic and sterile product manufacturing processes
Work Rights
External applicants must be eligible to work in the United States.