QA Manager:in

Roche; Basel; On-site; CHF 180,000 - 240,000; Full time

Job summary

Roche is seeking a Global Quality Manager to safeguard product quality and regulatory compliance for global clinical trials within the IMP Distribution Network. You will apply your expertise in quality systems and GxP processes to provide guidance and oversee complex distribution quality activities.

Key responsibilities include regulatory compliance, global QA oversight, deviation management, document control, inspections, and continuous improvement across the Roche network.

Qualifications

• Proven experience in Quality Assurance within GMP/GDP.
• Bachelor's degree in science, engineering, or related field.
• Fluent in German and English, both written and spoken.

Responsibilities

• Act as the Delegate of the Swiss Responsible Person (FvP) and lead final QA decisions.
• Maintain Global QA oversight for Roche IMP Distribution Network and PTDS-L.
• Lead Deviation Management and assess product quality impact of CAPAs.

Skills

QA & Compliance

GxP Knowledge

Regulatory Documentation

German & English

Education

Bachelor's degree in a relevant field

Job description

The Position

Join IMP Quality Distribution, a critical function within Global Quality Assurance. We are responsible for maintaining the quality and compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain. Our team acts as the appointed Delegate of the Swiss Responsible Person (FvP) and holds Global QA oversight over the entire IMP Distribution Network (Depots) and our key business counterpart, Global Clinical Supply Chain Management Distribution (PTDS-L). We drive continuous improvement and ensure adherence to international GMP/GDP standards.

Opportunity

We are seeking a highly motivated and experienced Global Quality Manager to step into a role of significant reach. This position is instrumental in safeguarding product quality and regulatory compliance for global clinical trials. You will utilize your expertise in quality systems and supply chain distribution knowledge to provide guidance and maintain oversight over complex GxP processes.

Key Differentiators & Core Functions

Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making. Global Oversight: Maintain Global QA oversight for the entire Roche IMP Distribution Network and its business counterpart, PTDS-L. Lead the Deviation Management process by performing product quality impact assessments. Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate. System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L). Inspection Management: Actively drive and support all GxP inspections and audits. Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and managing Expert Statements/Opinions. Clinical Study & Quality Operations: Review and approve IMP supply flowcharts, transfer requests, expert opinions, quality agreements, and manage clinical trial complaints across the Roche network. Compliance & Continuous Improvement: Drive network projects and improvement initiatives while ensuring strict adherence to GMP/GDP, Good Documentation Practices, and PQS training compliance.

Who You Are

QA & Compliance Expertise: You possess proven and comprehensive experience in Quality Assurance with a strong focus on compliance. You have deep knowledge of a regulated GxP environment (GMP/GDP) Educational Foundation: You hold a Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering). Regulatory Language Skills: You are a fluent speaker and writer in both German and English. Your fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring successful support during Health Authority Inspections.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.