Responsible Person; RP​/QP Profile

Overview

Option One Life Science Consulting is expanding its Swiss regulatory services and is currently seeking an experienced Responsible Person (RP) for the Swiss market to collaborate on consulting projects and market release activities.

This role is suited for a highly professional, assertive, and autonomous expert with strong regulatory authority interaction experience and a solid background in GMP/GDP compliance.

Fluent German (mandatory);
Professional English

The selected professional will act as Swiss Responsible Person (RP) under Swiss medic requirements and support clients operating in the pharmaceutical supply chain within Switzerland.

• Act as Responsible Person in accordance with Swiss medic GDP/GMP requirements
• Ensure compliance of medicinal products released to the Swiss market
• Oversight of GDP activities including storage, distribution, and transport controls
• Approval and maintenance of quality agreements with partners and service providers
• Management of deviations, complaints, recalls, and quality incidents
• Participation in internal audits and third-party audits
• Interface with Swiss medic during inspections and regulatory interactions
• Oversight of temperature monitoring, supply chain risk management, and qualification of logistics providers
• Support implementation and improvement of Quality Management Systems (QMS)
• Review and approval of SOPs and quality documentation
• Risk assessment and mitigation related to distribution activities
• Training and qualification oversight of relevant personnel
• Support clients during inspection readiness and regulatory remediation programs

• Proven experience as RP / QP / Senior GDP-GMP Quality professional
• Strong knowledge of Swiss GDP regulations and EU GDP guidelines
• Experience interacting with regulatory authorities
• Background in pharmaceutical manufacturing, distribution, or MAH environment
• Ability to work independently and represent the company toward authorities
• Strong communication and decision-making skills
• Consultancy mindset is a plus

Flexible collaboration (consulting / mandate-based / FTE)

Involvement in multiple client projects through Option One Life Science Consulting.