Senior Manager, Biosimilar QA & Compliance

Fresenius Kabi; North Carolina; On-site; USD 119,000 - 166,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Health benefits (medical, dental, and/

Vision coverage

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi in North Carolina seeks a Senior Quality Assurance leader to administer QA processes for biosimilar drug products at the Wilson facility. You will approve SOPs, validation documents, and discrepancy reports, ensuring cGMP compliance and successful product release.

You will coordinate with Regulatory Affairs and other QA functions, lead major projects, and participate in regulatory inspections to support continuous improvement and product quality.

Qualifications

• Leads QA processes for Biosimilars programs and ensures cGMP compliance.
• Oversees quality systems, change control, investigations, and product specifications.
• Partners with Regulatory Affairs, Sales, and Corporate QA to support inspections.

Responsibilities

• Establishes and administers QA processes for the Wilson facility.
• Approves SOPs, validation documents, and discrepancy reports.
• Provides guidance on cGMP to departments involved in release of biosimilar products.
• Manages QA department activities and resources; participates in major projects.
• Coordinates annual product quality reports and regulatory inspections.

Skills

Quality Assurance Leadership

Regulatory Compliance

cGMP

Process Improvement

Regulatory Liaison

Job description

Fresenius Kabi in North Carolina seeks a Senior Quality Assurance leader to administer QA processes for biosimilar drug products at the Wilson facility. You will approve SOPs, validation documents, and discrepancy reports, ensuring cGMP compliance and successful product release.

You will coordinate with Regulatory Affairs and other QA functions, lead major projects, and participate in regulatory inspections to support continuous improvement and product quality.