Senior Quality Lead

• Life Sciences - Quality Management
• Basel-Stadt
• Contracting
• Teilzeit, 100%
• Immediately - 12 months after start date/possible extension
• Quality Assurance, MDR, IVDR, GxP

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

Requirements:

• 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.