Beschreibung

We are looking for an experienced quality professional to join the IMP Quality Distribution team. In this role, you will help ensure the quality and compliance of Investigational Medicinal Products throughout the global clinical supply chain, in line with international GMP and GDP standards.

General Information

• Start date:
• Latest possible start date:
• Duration: 12 months
• Extension: very likely
• Location: Basel
• Workload: 100%
• Home Office: 40% possible, 60% on site
• Travel: none
• Team: 7 people
• Department: IMP Quality Distribution
• Working hours: standard working hours

Background

IMP Quality Distribution is part of Global Quality Assurance and is responsible for maintaining the quality and compliance of clinical trial materials across the global supply chain. The team provides QA oversight for the global IMP Distribution Network and works closely with key stakeholders in Global Clinical Supply Chain Management Distribution.

This position offers a global scope and plays an important role in safeguarding product quality, regulatory compliance and reliable supply for clinical trials.

Tasks and Responsibilities

• Act as Delegate of the Swiss Responsible Person / FvP for quality-related decision-making
• Maintain global QA oversight of the IMP Distribution Network and relevant Clinical Supply Chain interfaces
• Lead deviation management activities, including product quality impact assessments
• Review and assess final evaluations, quality statements and CAPA proposals from third parties
• Ensure that proposed CAPAs are appropriate and aligned with regulatory expectations
• Manage quality documentation and change records throughout their lifecycle
• Establish, review and approve internal procedures and external business documents
• Support and drive GxP inspections and audits
• Manage temperature excursion assessments for clinical trials
• Prepare, review and manage expert statements and quality opinions
• Review and approve IMP Supply & Release Flowcharts, transfer requests and expert opinions
• Establish and approve Master Quality Agreements and Quality Agreements
• Manage complaint processes for clinical trials within the Roche network
• Support quality-related and business-driven projects within the IMP Distribution network
• Drive continuous improvement activities
• Ensure compliance with GMP/GDP, Good Documentation Practices and internal PQS requirements

Requirements

• Bachelor’s degree in a relevant scientific or technical field, such as Pharmacy, Chemistry, Biology or Engineering
• At least 3 years of experience in Quality Assurance with a strong focus on compliance
• Strong knowledge of regulated GxP environments, especially GMP and GDP
• Experience with quality processes such as deviations, CAPA, change control, audits or inspections
• Fluent English skills, both written and spoken
• Independent, structured and quality-oriented working style
• Ability to assess complex quality topics and make well-founded decisions
• Strong communication skills when working with internal and external stakeholders

Nice to Have

• Experience with Veeva Vault QMS
• Previous Roche experience
• PTQ experience
• Experience in supplier management, especially with depots
• German language skills are an advantage

Ideal Profile

The ideal candidate is an experienced QA professional with a strong compliance mindset and solid knowledge of GMP/GDP requirements. They are confident in handling quality decisions, deviations, CAPA, documentation and inspection-related topics within an international environment. Experience in clinical supply chain, IMP distribution or supplier/depot management would be a strong advantage.