Strategic Supplier Quality & Audit Lead

PharmaLogic

United States

In loco

USD 120.000 - 190.000

Tempo pieno

9 giorni fa

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Descrizione del lavoro

PharmaLogic in the United States seeks a skilled Supplier Quality Assurance Manager to own supplier quality oversight for PET drug manufacturing operations, ensuring CGMP compliance across raw materials, components, and contract services. You will lead a team of auditors, manage qualification programs, and drive CAPA through the supplier lifecycle.

You will report to the Director of 212 Manufacturing Quality & Regulatory and partner with Operations, Supply Chain, and QA to embed quality

Competenze

Bachelor’s degree in Chemistry, Biology, Engineering, Pharmacy or related scientific discipline.
7+ years QA experience in FDA-regulated pharma, with supplier quality focus.
Leadership of auditors and experience building a risk-based supplier program.
Strong knowledge of 21 CFR Parts 210-212, ICH Q9/Q10, and FDA guidance on Quality Agreements.

Mansioni

Own and manage the supplier quality program for CGMP compliance and supplier oversight.
Lead the supplier audit team, set objectives, and review audit reports for accuracy.
Execute supplier qualification and annual risk-based audits, tracking CAPA closure.
Embed quality requirements in sourcing, supplier selection, and quality agreements.
Maintain Quality Agreements and manage supplier change notifications and COA reliance.
Oversee supplier non-conformances, root-cause analysis, and performance history.