Senior Quality Leader – GMP/GDP & Swiss RP

Daiichi Sankyo Europe GmbH; Zürich; On-site; CHF 120,000 - 180,000; Full time

Job summary

Daiichi Sankyo Europe GmbH in Switzerland seeks an experienced Quality Leader to act as Responsible Person (RP) for Swiss regulatory compliance, GMP and GDP oversight, and local Quality Management System maintenance.

You will collaborate with local stakeholders, review batches for release, manage change controls, investigations, and quality documentation, and support product recalls and regulatory inspections.

Qualifications

• University degree in Life Sciences (BSc/MSc/PhD) in Pharmacy, Chemistry, Biology, or related field.
• Eligible to act as RP/FvP under Swiss requirements for Swissmedic recognition.
• Strong GMP/GDP expertise with sound judgement on quality-critical matters.

Responsibilities

• Partner with local stakeholders to ensure Quality activities meet Swiss law, EU GDP and GMP.
• Maintain the local QMS at DSCH in accordance with Swiss law and EU GMP/GDP.
• Provide guidance to site leadership on routine supply activities and new product introductions.
• Act as Quality liaison between local operations and Corporate Quality for GMP/GDP.
• Review and approve QMS-related activities, investigations, changes and complaints.
• Release or reject batches for the Swiss market and ensure product specifications are met.
• Support regulatory authorities and customers on specialist pharmaceutical matters.

Skills

Fluency in English and German

Office programmes

Independent and accountable

Strong communication

Team player

Social competence

Decision making

Education

Life Sciences degree (BSc/MSc/PhD)

RP/FvP eligibility under Swiss regs

GMP/GDP regulatory knowledge

Tools

SAP HANA

Job description

Daiichi Sankyo Europe GmbH in Switzerland seeks an experienced Quality Leader to act as Responsible Person (RP) for Swiss regulatory compliance, GMP and GDP oversight, and local Quality Management System maintenance.

You will collaborate with local stakeholders, review batches for release, manage change controls, investigations, and quality documentation, and support product recalls and regulatory inspections.