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Fresenius Kabi

Global provider of therapies and devices

Manager Chemistry

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeWilson, NC, USAIn-person

About the Job

Requirements

  • Stay current with changing analytical chemistry requirements, methods, and pharmaceutical changes.
  • Provide expertise to support organizational needs as required.
  • Ensure department personnel are aware of the Environmental Management and Energy Management Systems and promote continual improvement in line with ISO 14001 and ISO 50001.
  • Ensure Health, Safety and Environmental requirements are met under ISO 14001.
  • Ensure Energy Management requirements are met under ISO 50001.
  • Ensure compliance with Occupational Health and Safety under ISO 45001.

Responsibilities

  • Manage activities associated with testing raw materials and finished goods to meet quality, regulatory, and customer requirements, routinely interacting with Manufacturing and Quality Assurance.
  • Direct and prioritize multiple laboratory work teams to provide timely and accurate testing of raw materials, in-process materials, and finished goods, demonstrating compliance with FK USA and FDA regulatory quality requirements.
  • Oversee staff administration to ensure team members are adequately trained, developed, motivated, and adhere to quality performance standards.
  • Plan and coordinate training schemes to develop cross-trained, self-directed work teams in line with total quality management concepts.
  • Evaluate and decide corrective actions in response to out-of-specification or out-of-trend situations.
  • Provide evaluation and quality control recommendations for new processes involving chemistry concerns or troubleshoot existing processes.
  • Assist in developing, administering, and maintaining departmental operating and capital budgets.
  • Represent the department in cGMP inspections and other audits as required.
  • Coordinate departmental staff to ensure departmental obligations conform to cGMP and FK USA policies and procedures.
  • Provide a work environment that supports people development, method improvement, and personal, departmental, and company goals.
  • Participate in reviewing annual product review documents related to the department.
  • Represent the department at applicable management review meetings.
  • Work with peers within the site and/or at other sites to develop and harmonize processes and procedures that improve compliance, capability, and capacity.

About the Company

Fresenius Kabi

Global provider of therapies and devices

Fresenius Kabi is a global healthcare company that provides medicines, medical devices, and services for the treatment of critically and chronically ill patients. Its portfolio includes biosimilars for autoimmune diseases and cancer, clinical nutrition products, infusion pumps and related disposables, blood collection bags and devices, and IV generics and fluids. It stands out with leading market positions in areas like blood collection and infusion materials and offers an integrated mix of pharma, nutrition, and MedTech offerings under the FutureFresenius strategy. Its goal is to shape the future of healthcare by expanding its global therapies and technologies, improving patient care, and delivering sustainable value for stakeholders.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Bad Homburg, Germany
Founded
1999

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