Senior Compliance Officer — GMP & Regulatory Audit Lead

Fresenius Kabi; Melrose (MA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Wellness program

Job summary

Fresenius Kabi in Melrose, MA is seeking a Compliance Officer to maintain Quality Systems from an FDA and global perspective. The role leads teams to identify and correct cGMP inadequacies and ensures audit readiness.

It requires expertise in deviation investigations, annual product reviews, and CAPA documentation. You will investigate process deviations, determine root causes, and initiate corrective actions, ensuring compliance with SOPs and regulatory requirements; excellent written and

Qualifications

• Bachelor's degree in Scientific or Engineering field.
• Minimum 3 years of experience in the pharmaceutical industry in compliance, technical writing, and/or regulatory affairs.

Responsibilities

• Completes or reviews deviation investigations and defines corrective actions to prevent recurrence.
• Gathers information from product data and assesses risk to future operations; maintains complaints in FK gCMW KabiTrack.
• Accountable for meeting closure targets per department management.
• Reviews manufacturing and laboratory 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 meeting commitments to authorities.
• Leads internal audit teams to inspect and remediate system noncompliance in the plant.
• Supports compilation of annual product quality review.
• Responsible for ensuring compliance with operating procedures.
• Assists in GAP analysis and risk assessments across manufacturing, laboratory, maintenance and engineering.
• Updates and maintains quality management systems and performs trend analysis.
• All employees must comply with health, safety, environment, energy and quality programs.

Education

Bachelor's degree in Scientific or Engineering degree

Job description

Fresenius Kabi in Melrose, MA is seeking a Compliance Officer to maintain Quality Systems from an FDA and global perspective. The role leads teams to identify and correct cGMP inadequacies and ensures audit readiness.

It requires expertise in deviation investigations, annual product reviews, and CAPA documentation. You will investigate process deviations, determine root causes, and initiate corrective actions, ensuring compliance with SOPs and regulatory requirements; excellent written and