Senior QA Manager, Biosimilars - Compliance & Impact

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

Benefits offered by this job

Bonus plan (14% target)

401(k) plan with company contributions

Paid vacation, holidays, and personal/

Health benefits (medical, prescription

Dental and vision coverage

Life insurance

Disability

Wellness program

Job summary

Fresenius Kabi USA seeks a senior Quality Assurance leader to administer LQA, compliance, QA document control, and QA critical systems for Biosimilar drug products at the Wilson site. You will oversee QA processes, lead major projects, and interact with Regulatory Affairs, Sales, Corporate QA, and external partners including regulatory agencies such as FDA and DEA.

The role includes managing QA teams, contributing to regulatory inspections, and driving continuous improvement and product transfer

Responsibilities

• Establishes and administers Quality Assurance processes for the Wilson facility supporting biosimilar drug product release.
• Reviews and approves SOPs, validation docs, and manufacturing discrepancy reports for Biosimilars; provides cGMP guidance.

Job description

Fresenius Kabi USA seeks a senior Quality Assurance leader to administer LQA, compliance, QA document control, and QA critical systems for Biosimilar drug products at the Wilson site. You will oversee QA processes, lead major projects, and interact with Regulatory Affairs, Sales, Corporate QA, and external partners including regulatory agencies such as FDA and DEA.

The role includes managing QA teams, contributing to regulatory inspections, and driving continuous improvement and product transfer