Senior Biosimilar QA & Compliance Leader

Fresenius Kabi USA; North Carolina; Sur place; USD 119 000 - 166 000; Plein temps

Avantages offerts par ce poste

401(k) with company contributions

Paid vacation, holidays and personal/​

Health, dental and vision coverage

Résumé du poste

Fresenius Kabi USA in Wilson, North Carolina is seeking a Quality Assurance leader to oversee LQA, compliance, document control, and critical systems for biosimilar drug products. You will guide cGMP practices, lead QA staff, and coordinate regulatory inspections to ensure timely product releases and continuous improvement across the plant quality organization.

Responsibilities include managing major projects, collaborating across Regulatory Affairs, Sales, and Corporate Quality Assurance, and

Responsabilités

• Establishes and administers Quality Assurance processes for Biosimilars release at the Wilson plant.
• Reviews SOPs, validation docs, and manufacturing deviation reports related to Biosimilars.
• Provides cGMP guidance to all departments involved in Biosimilar product release.
• Manages daily QA department activities and participates in major projects incl. contract manufacturing and facility renovations.
• Directs investigations of product complaints and prepares necessary documentation.
• Coordinates preparation and approval of Annual Product Quality Reports.
• Supports Regulatory/FDA inspections and pre-inspection reviews.

Description du poste

Fresenius Kabi USA in Wilson, North Carolina is seeking a Quality Assurance leader to oversee LQA, compliance, document control, and critical systems for biosimilar drug products. You will guide cGMP practices, lead QA staff, and coordinate regulatory inspections to ensure timely product releases and continuous improvement across the plant quality organization.

Responsibilities include managing major projects, collaborating across Regulatory Affairs, Sales, and Corporate Quality Assurance, and