Senior Manager, GxP Compliance Officer

Fresenius Kabi USA

. Lead, coordinate, verify and track global compliance activities within the pharmaceutical division .

Posted 10/9/2026full-timeMelrose Park • Illinois • United StatesSenior💰 $172,000 - $192,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in US-FDA compliance and cGMP regulations, with a strong focus on risk management, quality assurance, and effective communication with regulatory bodies. Proven ability to lead compliance initiatives, train staff, and manage complex projects within the pharmaceutical industry.

Highest-signal resume keywords

US-FDA Compliance ExpertiseCGMP KnowledgePharmaceutical Manufacturing ProcessesProject Management ExperienceStrong Analytical Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceRisk ManagementRoot Cause AnalysisValidation and QualificationAseptic ProcessesGxP AuditsQuality Management SystemsDrug Transfer ProcessesMock InspectionsFDA-483 CAPA Review

Soft Skills

Strong Communication SkillsTeam LeadershipInfluencing SkillsProblem-SolvingAbility to Manage Ambiguity

Tools & Technologies

Quality Management DocumentsSOPsGuiding DocumentsWork Instructions

Industry Keywords

Pharmaceutical IndustryCGMPICH GuidelinesFDA-483 ObservationsMutual Recognition AgreementsAseptic FillingTerminally Sterilized PharmaceuticalsLyophilized Pharmaceuticals

About the role

Key responsibilities & impact

Lead, coordinate, verify and track global compliance activities within the pharmaceutical division
Evaluate investigations and changes that could impact regulatory commitments
Identify and remediate plant quality and compliance risks using metrics, audit results and gap assessments
Support plants with strategy and compliance plans for identified gaps
Lead and manage working groups to ensure mitigation plans are executed
Prepare manufacturing sites and R&D Centers for US-FDA inspections
Train plant staff on general inspection aspects, behaviors and subject-matter-specific topics
Perform mock inspections to evaluate plant readiness
Design and deliver need-based training in response to identified gaps
Participate in and support US-FDA inspections, including inspection-room and back-office guidance
Support preparation of responses to FDA-483 observations
Independently review effectiveness of assigned FDA-483 CAPA
Support inspections by local authorities related to Mutual Recognition agreements
Identify new FDA cGMP trends and develop strategies to meet new expectations
Optimize and harmonize cGMP and quality-related processes
Prepare global quality management documents, including SOPs, guiding documents and work instructions
Contribute to, execute and manage global projects
Collaborate with corporate quality functions on strategic goals
Communicate findings and risks to plant management and senior quality management
Ensure compliance with company Health, Safety, Environment, Energy and Quality Management Systems

Requirements

What you’ll need

Minimum of Bachelor’s degree required
Advanced degree in chemistry, molecular biology, microbiology or engineering field is highly desirable
Accomplished US-FDA compliance expert
8+ years of experience, including practical experience in the pharmaceutical industry and/or US-FDA
Thorough knowledge of drug transfer processes, pharmaceutical manufacturing processes, aseptically filled, terminally sterilized and lyophilized pharmaceuticals, cGMPs, ICH guidelines and regulatory compliance
Professional experience in pharmaceutical industry, including technological understanding of manufacturing pharmaceuticals and combination products, aseptic processes, validation and qualification, risk management, root cause analysis and investigation management
Previous experience in executing and/or managing GxP audits or inspections preferred
Ability to effectively interact with and influence plant personnel and leadership, regulators, global partners or affiliates, industry executives and trade organizations
Established contacts with US-FDA beneficial
Strong analytical problem-solving experience
Prior experience leading and motivating teams to develop innovative, creative, robust and sustainable solutions
Ability to manage multiple complex situations involving ambiguity and uncertainty
Ability to travel frequently, both domestically and internationally
Project management experience
Experience working in a Quality Management System
Strong communication skills
English proficiency: ability to speak, read, write and understand English effectively
Bilingual English/Spanish preferred
Applicants must be authorized to work for any employer in the United States; employment visa sponsorship is unavailable

Benefits

Comp & perks

Bonus plan with a target of 14% of the base salary
401(k) plan with company contributions
Paid vacation, holiday and personal days
Employee assistance program
Medical, prescription drug, dental and vision coverage
Life insurance
Disability coverage
Wellness program