Senior Quality Manager<br /> <p>As a pivotal leader within our client organization, you will serve as the Quality Management Representative for the site, providing strategic direction to the QA team and ensuring our operations remain at the forefront of industry excellence.<br /><br /><br />Responsability</p><ul><li>Strategic Leadership: Guide the QA team to drive compliance and operational excellence across all quality functions, including NC/CAPA, change control, risk management, and complaint handling.</li><li>Operational Excellence: Partner with leadership and product segment managers to spearhead robust quality improvement initiatives and elevate overall performance.</li><li>Culture Champion: Foster a high-integrity culture of quality and GMP awareness, ensuring the site consistently meets or exceeds global regulatory standards.</li><li>Audit Management: Lead and coordinate all internal and external audits, serving as the primary interface for health authorities, notified bodies, and key customers.</li><li>QMS Evolution: Spearhead projects to harmonize and optimize quality processes, collaborating with global QA leaders to evolve the Quality Management System (QMS).</li></ul><p><br /><br />Profile</p><p>We are looking for a seasoned leader who balances technical mastery with a strategic, value-driven mindset.</p><ul><li>Educational Background: Advanced degree (BSc/MSc or equivalent) in Biology, Pharmaceutical Sciences, or a related field.</li><li>Regulatory Expertise: Deep knowledge of ISO 13485, QMSR / 21CFR820, MDSAP, and IVDD/R, specifically within the In-Vitro Diagnostics (IVD) sector.</li><li>Industry Experience: At least 10 years in Quality Assurance within the medical device or healthcare industry, including hands-on IVD experience.</li><li>Proven Leadership: Minimum of 8 years in a managerial role with a track record of developing high-performing, results-oriented teams.</li><li>Soft Skills: Exceptional interpersonal, negotiation, and communication skills, with the ability to turn quality activities into strategic organizational value.</li><li>Process Improvement: Experience in Lean or Six Sigma; a Green Belt certification is highly desirable.</li><li>Project Management: Solid background in managing complex quality projects and meeting deadlines in dynamic environments.</li><li>Language Proficiency: Fluency in French and English is required; a good command of German is considered a significant asset.</li></ul>

<p>Title: Quality Specialist<br />Location: Visp, Valais, Switzerland (On-site)</p><p>We are looking for a Quality Specialist with experience in deviation investigations and CAPA management within a GMP-regulated environment – ideally with strong knowledge of processes related to monoclonal antibodies.<br /><br />This role is critical to ensuring regulatory compliance, preventing recurring issues, and strengthening the quality system through effective corrective and preventive actions.</p><h3>Responsibilities:</h3><ul><li><p>Conduct thorough and well-documented investigations of deviations in the manufacturing process of monoclonal antibody-based products.</p></li><li><p>Perform root cause analyses using structured methodologies (e.g., 5-Why, Ishikawa, FMEA).</p></li><li><p>Develop, implement, and follow up on corrective and preventive actions (CAPAs).</p></li><li><p>Collaborate closely with teams from Production, QA, QC, and Development to comprehensively address incidents.</p></li><li><p>Ensure timely and GMP-compliant handling of all deviations and CAPAs.</p></li><li><p>Participate in internal and external audits, including the provision of relevant documentation.</p></li><li><p>Contribute to the continuous improvement of the quality management system.</p></li></ul><h3>Requirements:</h3><ul><li><p>Completed university degree in Pharmacy, Biotechnology, Chemistry, Engineering, or a related field.</p></li><li><p>At least 5 years of experience in a quality function within the pharmaceutical or biotechnology industry, ideally under GMP conditions.</p></li><li><p>Solid understanding of monoclonal antibody-related processes.</p></li><li><p>Proven experience in deviation investigation and CAPA management.</p></li><li><p>Knowledge of international regulations (EMA, FDA, ICH).</p></li><li><p>Independent working style with strong analytical and problem-solving skills.</p></li><li><p>Excellent English skills, both written and spoken.</p></li></ul><h3>Desirable:</h3><ul><li><p>Experience with biological products or biosimilars.</p></li><li><p>Familiarity with digital quality management systems (e.g., TrackWise, Veeva).</p></li><li><p>Training in continuous improvement methodologies (e.g., Lean, Six Sigma).</p></li></ul><p> </p>

<p>Für einen unserer Kunden, ein etabliertes und international tätiges Unternehmen im Pharmabereich mit Sitz in Winterthur, suchen wir zur Verstärkung des Teams per sofort oder nach Vereinbarung eine/n</p><h3>Batch Release Manager 100 %</h3><h4>Ihre Aufgaben</h4><ul><li><p>Klassifizierung und Beurteilung von Abweichungen sowie Koordination der Aktivitäten im Rahmen der Bearbeitung von Abweichungen, inkl. Sicherstellung des rechtzeitigen Abschlusses von Untersuchungen</p></li><li><p>Unterstützung bei der Ursachenanalyse und der Definition von Korrektur- und Vorbeugemassnahmen</p></li><li><p>Sicherstellung der Einhaltung von regulatorischen Anforderungen</p></li><li><p>Auswertung von Trends und Erhebung von KPIs</p></li><li><p>Unterstützung bei behördlichen Inspektionen und Audits</p></li></ul><h4>Ihr Profil</h4><ul><li><p>Abgeschlossenes naturwissenschaftliches Fach- oder Hochschulstudium (z.?B. Chemie, Pharmazie, Biologie, Physik)</p></li><li><p>Gutes Verständnis für GMP-Anforderungen und mindestens 5 Jahre relevante Berufserfahrung im GMP-Umfeld</p></li><li><p>Sehr gute Deutsch- und Englischkenntnisse</p></li><li><p>Durchsetzungsvermögen und ausgeprägte Kommunikationsfähigkeiten</p></li><li><p>Statistikkenntnisse von Vorteil</p></li></ul><h4>Ihre Vorteile</h4><ul><li><p>Dynamisches Arbeitsumfeld mit Entwicklungsmöglichkeiten</p></li><li><p>Möglichkeit zu teilweisem Homeoffice (abhängig von der Funktion)</p></li><li><p>Moderne und unkomplizierte Firmenkultur mit direkter Kommunikation</p></li><li><p>Gratis Parkplätze sowie gute ÖV-Anbindung in Gehdistanz</p></li></ul>