Associate Director, Quality Assurance - Parenteral

Eli Lilly and Company; Alzey; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

Ein innovatives Unternehmen sucht einen Associate Director für Qualitätsmanagement, um die parenterale Fertigung in Alzey zu leiten. Diese Schlüsselposition bietet die Möglichkeit, an der Spitze neuer Technologien zu arbeiten und eine starke Qualitätskultur zu fördern. Sie werden ein engagiertes Team führen und sicherstellen, dass alle Prozesse den höchsten Standards entsprechen. Wenn Sie über umfangreiche Erfahrung in der pharmazeutischen Industrie verfügen und eine Leidenschaft für Qualität haben, ist dies Ihre Chance, einen bedeutenden Einfluss auf die Zukunft der Gesundheitsversorgung zu nehmen.

Leistungen

Flexible Arbeitszeiten

Reisevergütung

Möglichkeiten zur beruflichen Weiterbildung

Qualifikationen

• Mindestens 7 Jahre Erfahrung in der pharmazeutischen Leitung mit QA-Erfahrung.
• Fließend in Englisch und Deutsch mit On-Site-Präsenz erforderlich.

Aufgaben

• Leitung des QA-Teams zur Unterstützung des Starts der parenteralen Produktion.
• Entwicklung des Betriebsbereitschaftsplans und Sicherstellung der Einhaltung von Verfahren.

Kenntnisse

Qualitätsmanagementsysteme

Regulatorische Anforderungen

Aseptische Prozesse

Kommunikationsfähigkeiten

Problem-Lösungsfähigkeiten

Ausbildung

Bachelor in Wissenschaft, Ingenieurwesen oder Pharmazie

Tools

SAP

Jobbeschreibung

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We are committed to our work and prioritize people. We seek individuals dedicated to making a positive impact globally.

Position Overview:

Lilly is expanding its manufacturing footprint globally to meet patient needs and support our future growth. We are seeking experienced quality assurance leaders to support our expansion in Alzey, Germany. This role offers an excellent opportunity to contribute to new manufacturing investments and pioneering technologies.

The Associate Director, Quality Assurance (QA) – Parenteral, is responsible for staffing, training, and leading the QA team supporting the start-up of parenteral manufacturing at the Alzey site. This includes oversight of project delivery, process development, operational readiness, startup, and validation of parenteral processes including dispensing, equipment preparation, formulation, filling, and visual inspection. The individual will oversee process development, qualification, validation, and help build a strong quality culture, ensuring site inspection readiness.

Responsibilities:

• Support the Site Quality Leader in developing the site organization, Quality Management System, and executing site quality operations.
• Ensure a safe work environment, leading safety initiatives for the quality team.
• Develop the site’s operational readiness plan, including quality processes and approval of operational procedures.
• Build a capable, diverse quality oversight team ensuring compliance with procedures for parenteral operations.
• Promote a strong quality culture through open communication, teamwork, and employee participation.
• Supervise, coach, and support team development, performance management, and a fair work environment.
• Delegate to achieve results, manage multiple priorities, and adapt to changing conditions.
• Partner with production and design teams for 24/7 quality oversight.
• Support Operational Excellence initiatives for performance monitoring and continuous improvement.
• Review and approve GMP documentation, including qualification protocols, reports, procedures, deviations, and change controls.
• Network with global and other parenteral sites to share best practices.
• Collaborate cross-functionally for metrics review, operational support, and issue management.
• Set HR and business goals, participate in strategic planning, and communicate project and production status.
• Lead inspection readiness activities and interact with regulatory agencies during inspections.

Basic Requirements:

• Bachelor's degree in science, engineering, or pharmaceutical field, or equivalent experience.
• At least 7 years of pharmaceutical leadership with QA experience, including cross-functional collaboration.
• Minimum 7 years supporting parenteral manufacturing operations.
• Fluent in English and German.
• On-site presence required.

Additional Skills/Preferences:

• Strong knowledge of Quality Management Systems and regulatory requirements.
• Experience with regulatory inspections, facility start-ups, equipment qualification, process validation, SAP, environmental monitoring, aseptic processes, and related systems.
• Excellent communication, technical aptitude, training, mentoring, and problem-solving skills.

Additional Information:

• Flexible working hours possible.
• Primary location in Alzey, Germany.
• Travel approximately 10-20%.
• Short-term assignment (6-9 months) in a Device Assembly and Packaging site prior to role start.

Lilly is committed to diversity and inclusion. If accommodations are needed during the application process, please complete the workplace accommodation request form. We do not discriminate based on age, race, religion, gender, sexual orientation, or other protected statuses.