Senior Quality Lead

Job description

# 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