Senior Quality Lead

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Senior Quality Lead.

• Start Date: ASAP
• Planned Employment Duration: 1 year with the possibility of extension
• Workplace: Basel
• Home Office: Possible, 2 days in a week
• Department: Audit (TLQB)
• Team: 5 people
• Working Hours: Standard

The Senior Quality Lead is an experienced Quality Professional who supports the organization through the development and delivery of Quality Assurance strategies, audits, and conclusions for various entities (e.g., molecules in development, post-approval products, affiliates, processes, programs). This role ensures effective implementation of Quality Assurance to stakeholders and Health Authorities by generating evidence and actionable data through complex audits and quality activities.

Possesses extensive experience within the pharmaceutical, biotechnology, or medical device industries, including comprehensive knowledge of product development life cycles and relevant GxP regulations, such as GCP, GVP, and IVD/MD. They should demonstrate at least 5 years of experience leading GxP audits and managing complex quality projects, complemented by a deep understanding of drug development processes and global regulatory landscapes. Proficiency in information systems—specifically regarding audit management and analysis reporting tools is required, as is prior experience in clinical operations or quality functions related to system validations.

• 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.
• Provide training to staff and ensure 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)
• 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.

Application Submission Deadline: 25.08.2026