Description

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