Sr. Manager Quality Assurance

• Responsible for the establishment and administration of Quality Assurance processes for the Wilson facility supporting the implementation and release of Biosimilar Drug Products at the plant manufacturing site. Administers, reviews, and approves standard operating procedures, validation documentation, and manufacturing discrepancy reports related to Biosimilars. Provides cGMP guidance to all departments engaged in the implementation and release of Biosimilar drug products.
• Assumes responsibilities for the daily functional activities and has authority to make decisions for the Wilson QA department in internal and external meetings. Assumes responsibilities for major projects, such as contract manufacturing, new products, or facility renovations, as assigned by the Director of Plant QA. Actively participates in and supports Continuous Improvement, and Product Transfer Teams.
• Manages the administration of the Quality system in the Quality Organization. Develops personnel, administers budget, and plans for future resource needs with regard to personnel, equipment, and facility.
• Directs investigations of product complaints for Biosimilar products and completion of appropriate documentation. Provides technical details as required in a manner consistent with the confidential and proprietary nature of the information. Interacts with the Medical Information Department as needed.
• Coordinates the preparation, review, and approval of the Annual Product Quality Reports.
• Participates in Regulatory/FDA inspections by providing information or expediting/obtaining information required by the inspectors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
• Develops human resources to better accomplish and perform in their duties as professional quality managers, supervisors, and technicians.

Additionally:

• Collaborates with the Environmental Management System Representative for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
• Collaborates with the Energy Management System Representative for ensuring that Energy Management Requirements are met under ISO 50001 standards.
• Collaborates with the Occupational Health and Safety Management Representative for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.