Manager, QA Compliance Fresenius Kabi

USA, LLC

life insurance, 401(k) United States, Illinois, Lake Zurich 3 Corporate Drive (Show on map) Sep 03, 2026

Job Summary The Manager, QA Compliance is responsible for supporting the company's short and long term goals for maintaining regulatory, ISO, and global compliance. Assist Senior Manager with coordinating and facilitating supplier management, internal audit, and quality agreement, as well as a back up to the Senior Manager. $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. 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, andwellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.