Senior Manager, Biosimilar QA & Compliance

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

Benefits offered by this job

401(k) contributions

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi Wilson is seeking a senior QA leader to administer Laboratory Quality Assurance, Compliance, QA Document Control, and Critical Systems for biosimilar drug product release. You will oversee procedures, validation, deviations, and product specifications while coordinating with Regulatory Affairs and FDA/DEA as needed.

You will manage QA staff, budget, and resource planning, and participate in regulatory inspections.

Qualifications

• Bachelor’s degree in a scientific field is required.
• Extensive experience in quality assurance or regulatory compliance within biopharma.
• Strong knowledge of cGMP and regulatory inspections.
• Experience with document control, change control, and CAPA processes.
• Proven leadership of QA teams and cross‑functional collaboration.

Responsibilities

• Establish and administer QA processes for the Wilson facility, supporting biosimilar products.
• Review and approve SOPs, validation docs, and discrepancy reports related to biosimilars.
• Provide cGMP guidance across departments involved in product release.
• Lead major projects or contract manufacturing and support continuous improvement.
• Coordinate with Regulatory Affairs and external agencies during inspections.

Education

Bachelor's degree in science

Job description

Fresenius Kabi Wilson is seeking a senior QA leader to administer Laboratory Quality Assurance, Compliance, QA Document Control, and Critical Systems for biosimilar drug product release. You will oversee procedures, validation, deviations, and product specifications while coordinating with Regulatory Affairs and FDA/DEA as needed.

You will manage QA staff, budget, and resource planning, and participate in regulatory inspections.