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Fresenius Medical Care

Senior cGMP Pharmaceutical Manager

Fresenius Medical Care

. Oversee and support quality assurance responsibilities at pharmaceutical/drug manufacturing sites .

Posted 9/16/2026full-timeRemote • Florida • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive expertise in cGMP quality assurance within pharmaceutical manufacturing, including leadership in FDA inspections, CAPA management, and regulatory compliance. Proficient in managing quality systems and processes to ensure adherence to industry standards and continuous improvement.

Highest-signal resume keywords
CGMP Quality AssuranceFDA Inspection ExperienceManagement Review LeadershipEQMS Proficiency21 CFR Compliance

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Quality AssuranceCAPA ManagementStatistical Process ControlProcess Capability AnalysisQuality Risk ManagementRegulatory ComplianceDeviation AnalysisChange Control ManagementPharmaceutical Quality SystemsBatch Disposition
Soft Skills
LeadershipCollaborationProblem-SolvingCommunicationTraining
Tools & Technologies
SAPQMSQTrackAgile
Industry Keywords
Pharmaceutical ManufacturingRegulatory AuditsICH GuidelinesEU GMPContract Manufacturing Organization

About the role

Key responsibilities & impact
  • Oversee and support quality assurance responsibilities at pharmaceutical/drug manufacturing sites
  • Provide cGMP strategic and operational quality leadership and guidance across batch disposition, CAPA management, validation, supplier quality, regulatory inspections, management reviews, and related systems and processes
  • Partner with Manufacturing, Regulatory Affairs, Supply Chain, and R&D to embed a culture of quality and ensure uninterrupted, compliant supply
  • Lead and demonstrate cGMP knowledge and expertise, including training
  • Provide solutions and resolutions for deploying quality systems and processes
  • Participate in FDA inspections and other regulatory audits
  • Engage and support pharmaceutical/drug sites to ensure cGMP requirements are met
  • Guide pharmaceutical/drug-related processes and system improvements and changes
  • Work with manufacturing sites and site quality personnel to ensure requirements, compliant procedures, and adherence are in place
  • Assess effectiveness of pharmaceutical/drug requirements at sites
  • Provide independent input into in-process and finished product results, as appropriate
  • Analyze deviations, OOS results, complaints, and audit findings to identify systemic quality issues
  • Escalate critical quality issues to senior leadership and Regulatory Affairs
  • Provide input into Management Reviews in accordance with ICH Q10 and site QMS requirements
  • Compile and present Management Review data, including CAPA trends, deviation metrics, audit outcomes, product quality reviews, regulatory intelligence, and resource assessments
  • Maintain compliant, audit-ready Management Review records and use outcomes to drive continuous improvement and resource allocation
  • Analyze product and process data trends to assess state of control and identify improvement opportunities
  • Manage the change control program where appropriate
  • Serve as quality representative during FDA pre-approval, surveillance, and for-cause inspections
  • Prepare sites and personnel for regulatory inspections
  • Develop and manage responses to FDA Form 483 observations and Warning Letters with Regulatory Affairs
  • Perform other duties as assigned

Requirements

What you’ll need
  • Bachelor’s degree in chemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline (required)
  • Minimum 10+ years of quality assurance experience in pharmaceutical drug product manufacturing
  • Minimum 5+ years in a senior QA leadership role with direct people management responsibility
  • Hands-on experience with FDA inspections including Form 483 responses and remediation
  • Demonstrated experience leading Management Reviews and presenting to site and executive leadership
  • Deep expertise in 21 CFR Parts 4, 210 and 211
  • Strong working knowledge of ICH guidelines: Q7, Q8, Q9, Q10, Q11
  • Proficiency in eQMS platforms (e.g., SAP, QMS, qTrack, Agile etc.)
  • Familiarity with contract manufacturing organization (CMO) oversight is a plus
  • Experience with statistical process control (SPC), process capability analysis, and quality risk management (ICH Q9) is a plus
  • Familiarity with FDA guidance documents on process validation, data integrity (21 CFR Part 11), and pharmaceutical quality systems is a plus
  • Knowledge of EU GMP Annex requirements is advantageous for global supply programs is a plus
  • Ability to work across time zones for North American multi-site coordination
  • Ability to respond to urgent regulatory or quality events outside of standard hours
  • Travel up to 15% as required

Benefits

Comp & perks
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off
  • Parental leave
  • Potential for performance-based bonuses depending on company and individual performance
  • Reasonable accommodation for individuals with disabilities