Senior Audit & Inspection Manager (m/f/d)

CHEPLAPHARM Arzneimittel GmbH; Berlin; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

CHEPLAPHARM Arzneimittel GmbH in Berlin is seeking an experienced Regulatory Auditor to manage global and internal audits, ensuring compliance and operational excellence across functions.

You will coordinate outsourcing, drive inspection readiness, CAPA management, and stakeholder alignment, supported by a Master’s degree and at least 7 years in the pharmaceutical regulatory field.

The role offers a collaborative, international environment with flexible working models.

Qualifikationen

• Master’s degree in a relevant field (natural sciences, pharmacy or medicine).
• Minimum 7 years of relevant professional experience.
• Solid understanding of global regulatory requirements (FDA, EMA, Swissmedic) and inspection processes.

Aufgaben

• Manage, coordinate and conduct global and internal audit and inspection activities.
• Distribute and prioritize tasks within the team to support efficient collaboration across functions.
• Foster strong cross-functional alignment and act as a key contact for internal and external stakeholders.
• Oversee outsourcing activities and structured execution of external audits, including planning, risk assessment, and follow-up.
• Support and implement inspection readiness initiatives, including audit responses, root cause analyses, and CAPA management.

Kenntnisse

Regulatory knowledge

Stakeholder management

Communication skills

Cross-functional collaboration

Audit coordination

Ausbildung

Master’s degree in natural sciences/pharmacy/medicine

Jobbeschreibung

We are an owner-managed, globally active company in the specialty pharmaceuticals sector with a clear mission: to be THE sustainable platform for long-established and trusted pharmaceutical brand products in various therapeutic areas. As a reliable partner to the research-based pharmaceutical industry, CHEPLAPHARM ensures the availability and supply of these medicines for the global market. This benefits not only our partners, but also patients around the world. We are proud that our specialised business model has enabled us to become one of the world's leading companies in the acquisition of original preparations within 20 years, and we continue to grow. The aspiration of our approximately 800 employees: Together, we want to ‘ACHIEVE MORE’.

What makes your day with us special

• Manage, coordinate and conduct global and internal audit and inspection activities to ensure compliance and operational excellence
• Distribute and prioritize tasks within the team while supporting efficient collaboration across functions
• Foster strong cross-functional alignment and act as a key contact for internal and external stakeholders
• Oversee outsourcing activities and maintain structured execution of external audits, including planning, risk assessment, and follow-up
• Support and implement inspection readiness initiatives, including audit responses, root cause analyses, and CAPA management

What sets you apart

• A Master’s degree in a relevant field, i.e. generally in the natural sciences, pharmacy or medicine
• At least 7 years of relevant professional experience.
• Solid understanding of global regulatory requirements (e.g., FDA, EMA, Swissmedic) and inspection processes
• Strong coordination and stakeholder management skills with the ability to operate across multiple interfaces
• Excellent communication skills and the ability to influence and build long-term professional relationships

What we offer you besides the job

Corporate culture & internationality

A growing company with a diverse, open working environment and employees from around 40 countries.

Flexible working models & work-life balance

Individually customisable working models, including the option to work from another EU country for up to two months per year. Working time account with compensatory time off and 30 days of holiday.

Individual benefits & pension provision

Flexible benefits budget, e.g. for increased company pension provision, fitness and health offers or subsidies for travel and meal costs.

Discounts & additional benefits

Access to the corporate benefits platform with discounts at hundreds of partner companies.

Further development & team culture

Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion and celebrate successes together.