Pharma Quality Compliance Lead - Audits & CAPA

Fresenius; Melrose Park (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Compliance Officer to ensure FDA and global quality system compliance. You will lead deviation investigations, CAPA activities, and regulatory documentation reviews, guiding audits and cross‑functional teams to uphold high standards.

The role requires a Bachelor’s degree in a scientific or engineering field and at least 3 years in pharmaceutical compliance or regulatory affairs. English proficiency is essential for policy and training materials.

Qualifications

• Bachelor's degree in Scientific or Engineering degree.
• Minimum 3 years of pharma industry experience in compliance, technical writing, and/or regulatory affairs.
• English proficiency required to read, write and communicate policies and training materials.

Responsibilities

• Completes or reviews deviation investigations and defines necessary corrective actions.
• Gathers information from product, risk to future operations, and maintains complaint data in gCMW KabiTrack systems.
• Accountable for commitments to close targets with department management.
• Reviews analytical documentation for accuracy and regulatory compliance.
• Serves as the compliance SME for internal audits and supports regulatory authority audits.
• Coordinates information for regulatory requests and assists in compliance with regulatory commitments.
• Leads internal audit teams to inspect and remediate noncompliance in the plant.
• Supports compilation of annual product quality reviews and ensures SOP compliance.
• Aids in GAP analysis and risk assessments across manufacturing, lab, and maintenance areas.

Skills

Regulatory compliance

Technical writing

Audit readiness

Quality systems

Education

Bachelor's degree in Scientific or Engineering field

Tools

FK gCMW KabiTrack

Job description

Fresenius Kabi in Melrose Park, IL seeks a Compliance Officer to ensure FDA and global quality system compliance. You will lead deviation investigations, CAPA activities, and regulatory documentation reviews, guiding audits and cross‑functional teams to uphold high standards.

The role requires a Bachelor’s degree in a scientific or engineering field and at least 3 years in pharmaceutical compliance or regulatory affairs. English proficiency is essential for policy and training materials.