Senior Quality Lead

Senior Quality Lead #

(m/f/d)

Freelance/temporary employment for a project

Basel

Start date: asap

Reference number: 890604/1

Responsibilities ###

• 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
• 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
• Play a lead role in inspection preparation and management as well as providing training to staff and ensuring relevant materials are prepared for regulatory review
• Lead assigned goals and initiatives and drive the development or revision of PDQ processes
• Maintain and influence partnerships with senior business stakeholders and PDQ domains
• Facilitate cross-functional collaboration to ensure quality standards are met globally
• Expert knowledge in GxP regulations (FDA, EU, ICH guidance) and internal policies
• Ensure all activities are conducted in compliance with regulatory and company requirements

Profile ###

• 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)
• Solid 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
• 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 organization

Benefits ###

• Fascinating, innovative environment in an international atmosphere
• A very renowned company