Senior Quality Lead

ELAN Personal AG; Basel; Vor Ort; CHF 130.000 - 165.000; Vollzeit

Zusammenfassung

Roche Switzerland in Basel is seeking a Senior Quality Lead to guide QA strategies, audits and regulatory conclusions across development and post-approval activities. You will partner with global stakeholders to ensure GxP compliance and robust quality data for Health Authorities.

The role demands leadership in audit programs, inspection readiness, PDQ process development, and staff training, with a strong emphasis on cross-functional collaboration and delivering clear, actionable insights to

Qualifikationen

• Bachelor's degree or equivalent in a scientific or quality-related field.
• Significant experience in the pharmaceutical/biotech/medical device industry with GxP regulations (FDA, EU, ICH).
• Min. 5 years experience leading GxP audits and managing complex quality projects.
• In-depth knowledge of drug development processes and global regulatory landscapes.
• Fluency in written and spoken English; multilingual skills desirable.

Aufgaben

• Design and implement quality strategies across molecules/products/processes/affiliates.
• Lead and perform complex audits and quality assessments.
• Prepare for inspections and manage regulatory readiness with authorities.
• Drive PDQ goals and develop or revise PDQ processes.
• Foster cross-functional collaboration with global stakeholders to meet quality standards.
• Provide staff training and ensure materials for regulatory review are prepared.

Kenntnisse

QA Leadership

GxP Audits

Stakeholder management

Analytical thinking

Regulatory knowledge

Ausbildung

Bachelor's degree in scientific/quality field

Advanced degree preferred

Tools

Audit management tools

Analysis reporting tools

Jobbeschreibung

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