Sr. Manager Quality Assurance

Fresenius Kabi•Wilson, NC

About The Position

Responsible for administering Laboratory Quality Assurance (LQA), Compliance, QA Document Control, and QA Critical Systems to support timely delivery of results and company objectives, and for Quality Assurance activities related to implementation and release of Biosimilar Drug Products. The role oversees quality-system procedures, validation, change control, manufacturing discrepancy investigations, cGMP and regulatory compliance, product specifications, product stability programs, and annual product reviews. It participates in regulatory inspections at the Wilson facility and may lead major projects or contract manufacturing assignments. The position interacts with Regulatory Affairs, Sales, Corporate Quality Assurance, Fresenius Kabi Swiss Biosimilars functions, and regulatory agencies including the FDA and DEA, and manages direct reports in quality assurance functions supporting Biosimilars. The role establishes and administers Quality Assurance processes for the Wilson facility, provides cGMP guidance to departments, oversees quality-system activities, and directs investigations and documentation for Biosimilar product complaints. It also manages personnel development, budgeting, and future resource planning for personnel, equipment, and facilities. The position supports continuous improvement, product transfer teams, annual product quality reporting, and preparation for regulatory inspections. It collaborates with management-system representatives on environmental, energy, health, and safety requirements under ISO 14001, ISO 50001, and ISO 45001. The company’s primary business language is English. The successful candidate must be able to speak, read, write, and understand English effectively to perform the essential functions of the role in a regulated work environment. The position is at-will; employment is not guaranteed or permanent.

Requirements

Ability to speak, read, write, and understand English effectively to perform the essential functions of the position, including understanding workplace policies, procedures, training materials, and communications.
The job description does not specify a required degree or minimum years of experience.

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 implementation and release of 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 administration of the Quality system in the Quality Organization.
Develop personnel, administer the budget, and plan future resource needs for personnel, equipment, and facilities.
Direct Biosimilar product complaint investigations and ensure appropriate documentation is completed.
Provide technical details 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 requested by inspectors.
Schedule and conduct pre-inspection reviews of operations and follow up where corrective action is required.
Develop quality managers, supervisors, and technicians to help them perform their duties effectively.
Collaborate with the Environmental Management System Representative to ensure Health, Safety, and Environmental requirements under ISO 14001 are met.
Collaborate with the Energy Management System Representative to ensure Energy Management requirements under ISO 50001 are met.
Collaborate with the Occupational Health and Safety Management Representative to ensure compliance with ISO 45001 requirements.