Team Leader IPI - Quality Operations

1. Operations Inspection Management

• Ensure smooth daily IPI operations within Press Manufacturing
• Coordinate inspection activities across multiple operational areas, einschließlich flexografischer und digitaler Druckproduktion + Faltmaschinen
• Monitor daily production schedules and proactively address operational constraints or delays
• Ensure timely completion of inspection activities aligned with manufacturing priorities
• Support inspection execution when operationally required
• Provide visibility on inspection status and operational priorities to management
• Ensure effective shift handover and continuity between teams
• Support manufacturing coverage planning, including overtime coordination when needed

2. Team Management

• Lead, supervise, and support IPI inspectors in daily operations
• Maintain strong shop floor presence and accessibility
• Ensure inspectors comply with established inspection standards and procedures
• Monitor employee performance and support achievement of departmental goals and KPIs
• Provide regular performance feedback and contribute to PMD processes
• Support employee engagement, accountability, and team development
• Promote a positive and collaborative team environment
• Support conflict resolution and day-to-day team management activities

3. Training People Development

• Ensure onboarding and proper integration of new employees
• Ensure all inspectors are appropriately trained and qualified for their activities
• Evaluate employee competency and maintain training compliance
• Support continuous learning and development opportunities
• Promote team versatility and operational flexibility
• Establish and support annual development objectives for team members

4. Quality, Safety Compliance

• Ensure compliance with SOPs, WIs, Master Forms, customer protocols, and cGMP requirements
• Maintain a safe and compliant working environment
• Promote a strong quality culture within the department
• Support investigations related to: Beschwerden, Abweichungen, Qualitätsereignisse, Auditbeobachtungen
• Participate in internal and client audits and support audit readiness activities
• Ensure accurate completion and review of departmental documentation and checklists
• Conduct all activities in accordance with Thermo Fisher safety standards and GMP requirements

5. Cross-functional Coordination Communication

• Coordinate activities with: Produktion, Qualitätssicherung, Etikettendesign, Planung/Administration, IT, anderen operativen Abteilungen
• Work closely with Press Manufacturing leadership to ensure production priorities are achieved
• Partner with Engineering and IT teams on equipment qualifications, validations, and system updates
• Communicate effectively with vendors regarding automated inspection equipment improvements or issues
• Provide timely responses to internal and external stakeholders when operational issues arise
• Participate in daily operational meetings and escalation discussions

6. Continuous Improvement Performance Management

• Drive continuous improvement initiatives through PPI and JDI projects
• Identify operational inefficiencies and support implementation of corrective actions
• Support process optimization initiatives within IPI operations
• Monitor and report departmental metrics and operational KPIs
• Maintain accurate area data collection and reporting
• Contribute to standardization and best practice implementation
• Support implementation and revision of SOPs, WIs, and Master Forms

7. Reporting Operational Support

• Escalate operational risks, quality concerns, and resource constraints proactively
• Provide operational updates and inspection status visibility to management
• Support decision-making through clear communication and reporting
• Assist leadership in maintaining operational continuity and customer satisfaction
• Support aggressive production timelines while maintaining the highest quality standards

Ihr Profil

• High School Diploma oder GED erforderlich
• Associate Degree bevorzugt
• 2+ Jahre Erfahrung in der Inspektion und/oder Korrekturlesen erforderlich
• 2+ Jahre Erfahrung in der pharmazeutischen, klinischen, Verpackungs-, Etikettierungs- oder verwandten GMP-Bereichen bevorzugt
• Frühere Führungs- oder Aufsichtserfahrung bevorzugt
• Erfahrung in QA/QC, Fertigung, Verpackung oder klinischen Abläufen wird als Vorteil angesehen
• Starkes Wissen über GMP- und regulatorische Anforderungen
• Starke organisatorische und Priorisierungsfähigkeiten
• Fähigkeit, mehrere Aufgaben in einem schnelllebigen Umfeld zu managen
• Starke Kommunikations- und zwischenmenschliche Fähigkeiten
• Starke Aufmerksamkeit für Details und Dokumentationsgenauigkeit
• Fähigkeit, effektiv mit vertraulichen Informationen zu arbeiten
• Kenntnisse in Microsoft Office-Tools (Word, Excel, PowerPoint, Outlook)

Schlüsselkompetenzen

• Starke Führungs- und Teamkooperationsfähigkeiten
• Hohe Verantwortung und Eigenverantwortung
• Fähigkeit, Entscheidungen zu treffen und operationale Herausforderungen effektiv zu lösen
• Starke Problemlösungsmentalität
• Flexibilität und Anpassungsfähigkeit in einem sich verändernden Betriebsumfeld
• Fähigkeit, unter Druck zu arbeiten und enge Fristen einzuhalten
• Starker Kunden- und Qualitätsfokus
• Starke Engagement und Präsenz am Arbeitsplatz