About this role
Senior Quality Lead -------------------
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