TK
Senior Quality Audit & Inspections Manager (m/w/d) – Pharma
Triga Consulting GmbH & Co KG
Contract type
Ongoing
Work mode
Hybrid · 3 days/week in office · Berlin, Germany · Frankfurt am Main, Germany
Experience
Senior · 8+ years
Job description
Senior role planning, coordinating and conducting internal and global audits and inspections for an international pharmaceutical company, ensuring compliance and inspection readiness.
At a glance
- Employment
- Full-time · Employee (employment agreement)
- Work mode
- Hybrid · 3 days/week in office · Berlin, Germany · Frankfurt am Main, Germany
- Languages
- German
What you'll do
- Plan, coordinate and conduct internal and global audits and inspections to ensure compliance and operational excellence
- Coordinate and prioritize tasks within the team and foster efficient collaboration
- Work closely with internal departments and act as central contact for internal and external stakeholders
- Manage external audits including planning, risk assessment, execution and structured follow-up
- Contribute to inspection readiness measures and coordinate audit responses, root cause analyses and CAPA measures
What we're looking for
- Completed master's degree in a relevant field such as natural sciences, pharmacy or medicine
- At least 8 years of relevant experience in audit, inspection or quality assurance in the pharmaceutical industry
- Solid knowledge of international regulatory requirements, especially FDA, EMA and Swissmedic
- Good understanding of regulatory inspection processes and requirements for sustainable inspection readiness
- Strong coordination and stakeholder management skills and experience working with different departments
- Excellent communication skills and ability to bring different interests together and build sustainable relationships
- Structured, solution-oriented and independent working style with willingness to travel internationally
Benefits
- A growing company with an international and diverse working environment
- Flexible working models
- Working time account with the option of time off in lieu and attractive vacation arrangements
- Individually usable additional benefits and company pension offers
- Subsidies for selected health, mobility and catering offers
- Internal and external training aligned with your career goals
- Company and team events and further employee offers