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 Afonso.
Basel-Stadt Quality Lead GxP GCP GVP IVD MD Audit Projects Drug Development Management Global Regulatory Reporting jid53408bbss jit0834ss jiy26ss
Senior Quality Lead Arbeitgeber: ELAN Personal AG
Roche Schweiz bietet eine herausragende Arbeitsumgebung für Ingenieure in der Qualifizierung und Validierung, die nicht nur ihre technischen Fähigkeiten einbringen, sondern auch aktiv zur Stabilität und Weiterentwicklung der Produktion beitragen möchten. Mit einem modernen Campus in Rotkreuz, der eine zentrale Lage und zahlreiche Weiterbildungsmöglichkeiten bietet, fördert das Unternehmen eine dynamische und motivierte Teamkultur, in der Verantwortung und Zusammenarbeit großgeschrieben werden. Hier haben Sie die Möglichkeit, in einem der bedeutendsten Pharmaunternehmen der Welt zu arbeiten und Ihre Karriere in einem regulierten Umfeld voranzutreiben.
