$135K - $142K based on experience
• Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and 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.
Hybrid role: Onsite 3 days per week
Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.Responsibilities
Assist with coordinating and facilitating activities associated with supplier management program and support qualification of new and existing suppliers
- Assist with annual external audit plan with Global Procurement
- Coordinate, perform, and assist team members with supplier qualification activities
- Coordinate and maintain Approved Vendor List
Assist and support local, regional, and global departments with their questions/requests relating to suppliers
- Perform or assist with supplier risk assessment for non-compliance (i.e. FDA WL, etc.) inspection outcome
- Collaborate with cross-functional groups and complete supplier (re)qualification activities
- Interface with suppliers for audits (on-site, virtual, hybrid, or document) and requests (re)qualification documentation, as needed
- Perform supplier (re)qualification audit, as needed
- Collect and review supplier (re)qualification documentation
- Prepare supplier (re)qualification reports or assessment/evaluation reports
- Update and maintain regional (US QA Compliance) supplier tracking databases
- Update global supplier tracking databases
- Perform investigative task in KabiTrack for supplier change notification and manage until closure
Assist with coordinating and facilitating activities associated with Regional internal audit program
- Perform annual risk assessment for annual internal audit plan
- Assure internal audits are scheduled, conducted, and closed
- Participate in internal audit as a Lead or Co-auditor
- Plan, prepare, and conduct internal audit
- Collaborate as Lead or Co-auditor with other auditors (Lead or Co-auditor) to draft audit report, review CAPA Plan, and issue audit closure
- Interface with auditees
- Update and maintain internal audit tracking database
Assist with coordinating and facilitating activities associated with Quality Agreement
- Coordinate and manage the update to Global Procurement Quality Agreement database
- Coordinate and participate in quarterly Global Procurement Quality Agreement review
- Coordinate and perform regional periodic review of Quality Agreements
- Coordinate, negotiate, and support supplier Quality Agreement according to defined business relationship with suppliers
- Coordinate, negotiate, and support inter-company quality agreement according to defined business relationship with other non-FK USA entities
- Coordinate, negotiate, and collaborate with cross-functional groups and/or suppliers to draft, review, and/or finalize quality agreement
- Update global and regional Quality Agreement databases
Assist with preparing monthly management review presentation
- Coordinate monthly supplier data for product APQR as requested from Production Units
- Assist and perform Implementation Assessment for Instructive Global QM Documents
- Provide and support Annual Supplier Evaluation Coordinate and assist team members in supporting internal, external, customer, and regulatory inspection, as needed
- Support maintenance or process improvement of programs for supplier management, internal audit, and quality agreement, as needed
- Act as back up in the absence of Senior Manager, with support from VP, NAM Quality
Requirements
- Must have a Bachelor's degree in the sciences with 8+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry.
- Must have an in depth knowledge of current GMP and related quality systems.
- Must possess strong leadership, communication, interpersonal skills, negotiation and problem resolution skills.
- Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company's needs.
- Must be able to function independently with minimal supervision.
- 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.
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.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. 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.
Skills Required
- Bachelor's degree in the sciences
- 8+ years of progressive QA/QC experience in the pharmaceutical or related regulated industry
- In-depth knowledge of current GMP and related quality systems
- Strong leadership, communication, interpersonal, negotiation, and problem-resolution skills
- Ability to organize, manage multiple tasks, and redirect focus based on company needs
- Ability to function independently with minimal supervision
- Effective English speaking, reading, writing, and comprehension skills
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint
