WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life‑changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Job Purpose

The QA Manager DACH Cluster / Responsible Person (RP) is accountable for ensuring GDP compliance and maintaining a robust Quality Management System (QMS) across Germany, Austria, Switzerland, and Liechtenstein. The role holder acts as the Responsible Person for the German Wholesale Distribution Authorisation (WDA) and provides structured oversight and support to the Swiss RP, ensuring consistent and compliant GDP operations across the DACH cluster.

The role also actively contributes to EMEA QA initiatives and regional projects, supporting harmonisation and continuous improvement across affiliates.

Responsibilities

Key Responsibilities:

Responsible Person (Germany)

Act as RP for the German Wholesale Distribution Authorisation (WDA), ensuring continuous GDP compliance and maintenance in line with EU, national legislation and internal standards.
Maintains effective QMS to support the distribution, supply, and marketing of pharmaceutical products in Germany and Austria.
Maintain oversight of routine stock reconciliation and any potential stock issues.
Deciding on the final disposition of returned, rejected, recalled or falsified products.
Host and lead audits and inspections
Ensure ongoing RP availability and regulatory knowledge.

Quality Assurance & GDP Oversight – DACH Cluster

Lead and continuously improve the DACH QMS.
Ensure adequate resources, facilities, and training.
Plan and conduct internal audits and support external audits.
Monitor and report Quality KPIs to local and regional management.
Maintain quality agreements with third party partners and relationships with competent authorities and key stakeholders.

GDP Oversight – Switzerland & Liechtenstein

Ensure outsourced GDP and QA activities are compliant.
Provide oversight and support to the Swiss RP.
Support audits, inspections, and service provider monitoring.

EMEA QA Activities

Support GDP related QA activities across EMEA.
Contribute to regional QA working groups and harmonisation initiatives.
Support regional QA projects, inspection readiness, and continuous improvement programmes.

Qualifications

Position Requirements

Eligibility to act as Responsible Person (RP) under EU and German regulatory requirements.
Academic degree in Life Sciences (Pharmacy preferred) or equivalent qualification.
Strong experience in pharmaceutical Quality Management Systems, GDP compliance, and distribution operations.
In‑depth knowledge of EU and local GDP legislation and quality standards (e.g. EU GDP Guidelines, ICH Q10, quality risk management).
Proven experience leading audits and hosting regulatory inspections.
Several years’ experience in QA management within the pharmaceutical industry, ideally within distribution and/or manufacturing environments.
Fluency in German and English (written and spoken)
Strong leadership, communication, and stakeholder‑management skills, with the ability to work effectively in a virtual, cross‑border environment.

Kyowa Kirin International is an equal opportunities employer.

#J-18808-Ljbffr