Senior Quality Lead (m/f/d)
Über uns
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.Aufgaben
- 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
Profil
- 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
Wir bieten
- Fascinating, innovative environment in an international atmosphere
- A very renowned company
Ihr Kontakt
Referenznummer
890604/1
Kontakt aufnehmen
Telefon:+41 44 225 50 00
E-Mail: positionen@hays.ch
Anstellungsart
Freiberuflich für ein Projekt