Senior Quality Lead

Senior Quality Lead #

(m/f/d)

Freelance/temporary employment for a project

Basel

Start date: asap

Reference number: 890604/1

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

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

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