Biosimilars QA Leader — Compliance, CI & Inspections

Fresenius Kabi; Wilson (NC); On-site; USD 119,000 - 166,000; Full time

Benefits offered by this job

401(k) contributions

Paid vacation

Holidays and personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi in Wilson, NC, seeks an experienced senior Quality Assurance leader to administer LQA, compliance, QA document control, and QA critical systems for Biosimilar drug products. The role ensures timely results delivery, oversees quality systems, validation, change control, deviation investigations, and cGMP compliance.

Interacting with Regulatory Affairs, Sales, Corporate Quality Assurance, and Fresenius Kabi Swiss Biosimilars, the position leads major projects and reports to the

Responsibilities

• Establish and administer QA processes for Biosimilar Drug Products at the Wilson facility.
• Review, approve SOPs, validation documentation, and manufacturing deviation reports.
• Provide cGMP guidance to all departments involved in implementation and release of Biosimilar products.
• Lead daily QA activities and major projects, including contract manufacturing or facility renovations, as assigned by the Director of Plant QA.
• Develop and administer the Quality system, budget, and future resource planning.
• Direct investigations of product complaints for Biosimilar products and document outcomes.
• Coordinate preparation, review, and approval of Annual Product Quality Reports.
• Support Regulatory/FDA inspections and pre-inspection review activities.
• Develop personnel and support Continuous Improvement and Product Transfer Teams.

Job description

Fresenius Kabi in Wilson, NC, seeks an experienced senior Quality Assurance leader to administer LQA, compliance, QA document control, and QA critical systems for Biosimilar drug products. The role ensures timely results delivery, oversees quality systems, validation, change control, deviation investigations, and cGMP compliance.

Interacting with Regulatory Affairs, Sales, Corporate Quality Assurance, and Fresenius Kabi Swiss Biosimilars, the position leads major projects and reports to the