Job SummaryResponsible for administration of Laboratory Quality Assurance (LQA), Compliance, QA Document Control, and QA Critical Systems to assure timely delivery of results to manage the company objectives and Quality Assurance activities related to the implementation and release of Biosimilar Drug Products. Reviews procedures of quality systems, validation, change control, manufacturing discrepancy investigations, cGMP/regulatory compliance, and product specifications. Administers programs for product stability, annual product reviews, participates in regulatory inspections of the Wilson facility. Assumes responsibility for major projects or contract manufacturing as assigned by the Director, Plant Quality Assurance.
Interacts regularly with Regulatory Affairs, Sales, Corporate Quality Assurance, and Fresenius Kabi Swiss Biosimilars (FKSBS) functions. Routinely interacts with Regulatory Agencies including, but not limited to, FDA and DEA.
This position manages direct reports in respective quality assurance functions in support of Biosimilars.
Salary Range: $119,000 - $166,000
• Position is eligible to participate in a bonus plan with a target of 14% of the base salary
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
Responsibilities- 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.
Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, 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.
