Sr. Manager Quality Assurance

Fresenius Kabi USA•Wilson, NC

3d•$119,000 - $166,000

About The Position

The Sr. Manager Quality Assurance is responsible for administering Laboratory Quality Assurance, Compliance, QA Document Control, and QA Critical Systems at the Wilson facility. The role ensures timely delivery of results and supports company objectives and Quality Assurance activities related to implementing and releasing Biosimilar Drug Products. It reviews quality-system procedures, validation, change control, manufacturing discrepancy investigations, cGMP and regulatory compliance, and product specifications. The position also administers product stability and annual product review programs and participates in regulatory inspections. The position manages direct reports in quality assurance functions supporting Biosimilars and works with Regulatory Affairs, Sales, Corporate Quality Assurance, Fresenius Kabi Swiss Biosimilars functions, and regulatory agencies including the FDA and DEA. It assumes responsibility for major projects or contract manufacturing as assigned by the Director of Plant Quality Assurance. The role also collaborates with company representatives to support environmental, energy, and occupational health and safety management system requirements.

Requirements

Must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding English-language policies, procedures, training materials, and workplace communications.

Responsibilities

Establish and administer Quality Assurance processes for the Wilson facility supporting implementation and release of Biosimilar Drug Products.
Administer, review, and approve standard operating procedures, validation documentation, and manufacturing discrepancy reports related to Biosimilars.
Provide cGMP guidance to departments involved in implementing and releasing Biosimilar drug products.
Manage daily functional activities and make decisions for the Wilson QA department in internal and external meetings.
Assume responsibility for major projects, including contract manufacturing, new products, or facility renovations, as assigned by the Director of Plant QA.
Participate in and support Continuous Improvement and Product Transfer Teams.
Manage the Quality system in the Quality Organization.
Develop personnel, administer the budget, and plan future personnel, equipment, and facility resource needs.
Direct investigations of Biosimilar product complaints and ensure appropriate documentation; provide technical details as required while protecting confidential and proprietary information.
Interact with the Medical Information Department as needed.
Coordinate preparation, review, and approval of Annual Product Quality Reports.
Participate in regulatory and FDA inspections by providing or obtaining information for inspectors; schedule and conduct pre-inspection reviews and follow up on required corrective actions.
Develop employees to improve their performance as quality managers, supervisors, and technicians.
Collaborate with the Environmental Management System Representative to ensure Health, Safety, and Environmental requirements are met under ISO 14001.
Collaborate with the Energy Management System Representative to ensure Energy Management requirements are met under ISO 50001.
Collaborate with the Occupational Health and Safety Management Representative to ensure compliance with ISO 45001 requirements.