Senior Quality Lead (m/f/d)

Senior Quality Lead (m/f/d)

Freelance/Contracting project Basel Start date: asap Reference number: 890604/1

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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 (, 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, , 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