Senior QA Manager - Biosimilars & Compliance

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

Benefits offered by this job

Bonus plan (14% target)

Comprehensive benefits: 401(k), health

Job summary

Fresenius Kabi USA, LLC is seeking a senior leader to oversee Laboratory Quality Assurance, Compliance, QA Document Control, and QA Critical Systems for biosimilar drug products at the Wilson facility in North Carolina. The role ensures timely delivery of results and adherence to cGMP and regulatory requirements, with responsibility for major projects and regulatory inspections.

The position interacts with Regulatory Affairs, Sales, Corporate Quality Assurance, and Fresenius Kabi Swiss

Qualifications

• Leadership of quality assurance processes and documentation.
• Experience with cGMP regulatory requirements and QA systems.
• Ability to manage audits and regulatory inspections.

Responsibilities

• Establishes and administers QA processes for Biosimilar products at the Wilson plant.
• Reviews SOPs, validation docs, and deviation reports; provides cGMP guidance.
• Leads daily QA operations and participates in major projects including manufacturing contracts.
• Manages Quality system administration, budgeting, and resource planning.
• Drives regulatory inspections preparation and response; coordinates annual product reports.
• Develops staff and supports continuous improvement and product transfers.

Job description

Fresenius Kabi USA, LLC is seeking a senior leader to oversee Laboratory Quality Assurance, Compliance, QA Document Control, and QA Critical Systems for biosimilar drug products at the Wilson facility in North Carolina. The role ensures timely delivery of results and adherence to cGMP and regulatory requirements, with responsibility for major projects and regulatory inspections.

The position interacts with Regulatory Affairs, Sales, Corporate Quality Assurance, and Fresenius Kabi Swiss