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Open nowPosted 42 days ago

Senior Quality Lead

job-room.ch86,007 open roles

Where
BASEL, BS, Switzerland
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Your applicationOpen nowSenior Quality Leadjob-room.ch · BASEL, BS, Switzerland

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  2. 3.4%3 days
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  4. 14.2%14 days
  5. 34.1%30 days
This job: posted 42 days ago

The posting

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
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