Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Senior Quality Lead

Background:

The Senior Quality Lead is an experienced Quality Professional who supports the Roche/Genentech Organization through the development and delivery of Quality Assurance strategies, audits, and conclusions for various entities (e.g., molecules in development, post-approval products, affiliates, processes, programs). This role ensures effective implementation of Quality Assurance to stakeholders and Health Authorities by generating evidence and actionable data through complex audits and quality activities.

Tasks & Responsibilities:

• Design and Implementation of Quality Strategies:
  
  
  • Establish relationships with business stakeholders and lead the development of molecule/product/process/affiliate-level approaches with appropriate measures (CtQ Factors)
  • Analyze quality data to identify trends and risks, providing insights to business partners
• Delivery of Activities to Assess Quality Status
  
  
  • Lead and perform complex audits and quality assessments.
  • Synthesize individual audit issues into systematic conclusions and present findings and associated risks to senior stakeholders, ensuring quality data fulfills regulatory requirements and supports organizational goals
• Demonstration of Implementation to Health Authorities
  
  
  • Play a lead role in inspection preparation and management.
  • Provide training to staff and ensure relevant materials are prepared for regulatory review
• Execution of PDQ Goals
  
  
  • Lead assigned goals and initiatives and drive the development or revision of PDQ processes
• Networking:
  
  
  • Maintain and influence partnerships with senior business stakeholders and PDQ domains
  • Facilitate cross-functional collaboration to ensure quality standards are met globally
• Compliance:
  
  
  • Expert knowledge in GxP regulations (FDA, EU, ICH guidance) and internal policies
  • Ensure all activities are conducted in compliance with regulatory and company requirements

Must Haves:

• Bachelor’s degree or equivalent in a scientific or quality-related field. Advanced degree preferred
• Significant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP,GVP, IVD/MD Regulations)
• Min. 5 years experience in leading GxP audits and managing complex quality projects
• In-depth knowledge of drug development processes and global regulatory landscapes 
• Good understanding of Information Systems, e.g., audit management and analysis reporting tools
• Understanding of business operations and strategies
• Fluency in written and spoken English; bi or multi-lingual skills are desirable
• Clinical Operations experience or quality function in system validations
• Leadership and Stakeholder Management: Demonstrates exceptional ability to influence, negotiate, and mentor while effectively managing relationships with diverse stakeholders in global settings.
• Analytical and Strategic Thinking: strong data and digital literacy, with the critical thinking ability to synthesize complex or ambiguous information into clear, actionable insights.
• Execution and Independence: Combines strong organizational and project management skills with the capacity to work effectively—both independently and collaboratively—within international, agile matrix organizations.
• Communication: Utilizes advanced presentation and communication skills to drive decision-making and foster cross-functional collaboration

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Diana Afonso.

Basel-Stadt Quality Lead GxP GCP GVP IVD MD Audit Projects Drug Development Management Global Regulatory Reporting