Senior Quality Audit & Inspections Manager – Pharma

TRIGA Consulting GmbH & Co. KG

. Plan, coordinate, and conduct internal and global audits and inspections to ensure compliance and operational excellence .

Posted 11/10/2026full-timeFrankfurt am Main • GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in conducting audits and inspections within the pharmaceutical industry, ensuring compliance with international regulatory requirements such as FDA, EMA, and Swissmedic. Possesses strong coordination and stakeholder management skills to foster collaboration and maintain inspection readiness.

Highest-signal resume keywords

Master's Degree In Natural Sciences, Pharmacy, Or Medicine8 Years Of Experience In Auditing, Inspections, Or Quality AssuranceIn-Depth Knowledge Of International Regulatory RequirementsStrong Coordination And Stakeholder-Management SkillsExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

AuditingInspectionsQuality AssuranceRisk AssessmentRoot Cause AnalysisCAPA ActionsRegulatory ComplianceInspection Readiness

Soft Skills

CollaborationRelationship BuildingStructured ApproachSolution-Oriented MindsetIndependence

Industry Keywords

Pharmaceutical IndustryFDAEMASwissmedicRegulatory Inspection Processes

About the role

Key responsibilities & impact

Plan, coordinate, and conduct internal and global audits and inspections to ensure compliance and operational excellence
Coordinate and prioritize team activities while fostering efficient collaboration
Work closely with internal departments and serve as the central point of contact for internal and external stakeholders
Manage external audits, including planning, risk assessment, execution, and structured follow-up
Support inspection-readiness activities and coordinate audit responses, root cause analyses, and CAPA actions

Requirements

What you’ll need

Successfully completed a master’s degree in a relevant field, such as natural sciences, pharmacy, or medicine
At least 8 years of relevant professional experience in auditing, inspections, or quality assurance within the pharmaceutical industry
In-depth knowledge of international regulatory requirements, particularly those of the FDA, EMA, and Swissmedic
Good understanding of regulatory inspection processes and the requirements for maintaining sustainable inspection readiness
Strong coordination and stakeholder-management skills, with experience working across different functions
Excellent communication skills and the ability to align diverse interests and build strong, sustainable relationships
Structured, solution-oriented, and independent approach to work
Willingness to travel internationally

Benefits

Comp & perks

A growing company with an international and diverse work environment
Flexible working models
Working-time account with the option to take time off in lieu, as well as attractive vacation policies
Flexible additional benefits and occupational pension plans
Subsidies for selected health, mobility, and meal benefits
Internal and external training tailored to your professional goals
Company and team events, as well as additional employee benefits
Permanent employment contract
40 hours per week
Home office: 2 days per week