Sr. Manager Quality Assurance

301044 Fresenius Kabi USA, LLC; North Carolina; Presencial; USD 119.000 - 166.000; Tempo integral

Benefícios oferecidos por esta vaga

401(k) with company contributions

Paid vacation, holidays and personal/​

Health, dental and vision coverage

Resumo da vaga

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

Responsabilidades

• 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.

Descrição da vaga

Job Summary

Responsible 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.

Additional Information

We 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.

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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

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