Manager, QA Compliance

Jobtailor; Melrose Park (IL); On-site; USD 110,000 - 140,000; Full time

Job summary

Fresenius Kabi in Illinois seeks an experienced QA/QC professional to drive supplier qualification, internal audits, and quality agreement programs. You will coordinate audits, review CAPA plans, and support regulatory inspections while collaborating with cross-functional teams.

Ideal candidates bring 8+ years in pharmaceutical QA/QC, strong leadership, and deep GMP knowledge. This role requires independent work and effective communication with global stakeholders.

Qualifications

• Bachelor's degree in the sciences is required.
• 8+ years of progressive QA/QC experience in pharmaceutical or related regulated industry.
• In-depth knowledge of GMP and related quality systems.
• Strong leadership, communication, interpersonal, negotiation, and problem resolution skills.
• Organized and able to handle multiple tasks with minimal supervision.

Responsibilities

• Support regulatory, ISO, and global compliance objectives.
• Assist with supplier management, internal audits, and quality agreements.
• Coordinate supplier qualification and requalification activities.
• Assist with external audit planning and regional/global supplier tracking.
• Prepare audit reports and review CAPA plans and closures.
• Maintain internal audit tracking database and assist with regional audits.
• Support annual supplier evaluations and regulatory inspections.

Skills

Leadership

Communication

Interpersonal Skills

Negotiation

Problem Resolution

Education

Bachelor's degree in the sciences

Tools

KabiTrack

Audit Tracking Database

Supplier Management Software

Job description

Job Responsibilities

• Support the company’s short- and long-term goals for regulatory, ISO, and global compliance


• Assist the Senior Manager with supplier management, internal audit, and quality agreement programs


• Coordinate and facilitate supplier management activities and support qualification of new and existing suppliers


• Assist with the annual external audit plan with Global Procurement


• Coordinate, perform, and assist with supplier qualification and requalification activities


• Coordinate and maintain the Approved Vendor List


• Support local, regional, and global departments with supplier-related questions and requests


• Perform or assist with supplier risk assessments for non-compliance inspection outcomes


• Collaborate with cross-functional groups on supplier requalification activities


• Interface with suppliers for on-site, virtual, hybrid, or document audits and request qualification documentation


• Perform supplier requalification audits as needed


• Collect and review supplier qualification documentation


• Prepare supplier requalification and assessment/evaluation reports


• Maintain regional and global supplier tracking databases


• Investigate supplier change notifications in KabiTrack through closure


• Coordinate and facilitate the regional internal audit program


• Perform annual risk assessments for the internal audit plan


• Ensure internal audits are scheduled, conducted, and closed


• Participate in internal audits as Lead or Co-auditor


• Plan, prepare, and conduct internal audits


• Draft audit reports, review CAPA plans, and issue audit closures


• Interface with auditees and maintain the internal audit tracking database


• Coordinate and manage Global Procurement Quality Agreement database updates and reviews


• Coordinate and perform regional periodic reviews of Quality Agreements


• Coordinate, negotiate, and support supplier and inter-company Quality Agreements


• Collaborate with cross-functional groups and suppliers to draft, review, and finalize Quality Agreements


• Assist with monthly management review presentations


• Coordinate monthly supplier data for product APQR


• Assist with Implementation Assessments for Global QM Documents


• Provide and support Annual Supplier Evaluations


• Support internal, external, customer, and regulatory inspections


• Maintain and improve supplier management, internal audit, and quality agreement programs


• Act as backup for the Senior Manager with support from the VP, NAM Quality

Requirements

• Bachelor's degree in the sciences


• 8+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry


• In-depth knowledge of current GMP and related quality systems


• Strong leadership, communication, interpersonal, negotiation, and problem resolution skills


• Organized, detail-oriented, and able to handle multiple tasks and redirect focus based on company needs


• Able to function independently with minimal supervision


• Effective ability to speak, read, write, and understand English


• Applicants must be authorized to work for any employer in the United States; Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa now or in the future

Core Competencies

Demonstrates extensive experience in Quality Assurance and Quality Control within regulated industries, with a strong focus on supplier management, internal audits, and compliance with GMP standards. Proficient in coordinating supplier qualifications, conducting audits, and maintaining quality agreement programs.

Highest-signal resume keywords

• Quality Assurance Management


• Supplier Qualification


• Internal Auditing


• GMP Compliance


• Regulatory Inspections

ATS Optimization Keywords

Hard Skills

• Quality Management Systems


• Supplier Risk Assessment


• Audit Report Drafting


• CAPA Plans


• Supplier Tracking Databases


• Quality Agreement Negotiation


• Regulatory Compliance


• Supplier Management Programs


• GMP Knowledge


• Data Analysis

Soft Skills

• Leadership


• Communication


• Interpersonal Skills


• Negotiation


• Problem Resolution

Industry Keywords

• Pharmaceutical Industry


• Regulated Industry


• ISO Compliance


• Internal Audit


• Supplier Management

Tools & Technologies

• KabiTrack


• Audit Tracking Database


• Supplier Management Software