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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Associate, Quality Assurance – Materials Management is responsible for establishment and maintenance of the site materials management systems. The Materials Management associate provides quality oversight for the suppliers, service providers, and materials utilized by the site. This includes supplier and service provider onboarding, master data management, risk evaluation, establishment of Quality Agreements, and supplier performance monitoring. This position is essential for maintaining GMP compliance and ensuring inspection readiness.

Responsibilities:

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Leads, mentors, and coaches operations and support personnel on the materials management system.

• Works with site staff and global resources to establish site material suppliers for new site start-up.
• Coordinates the appropriate tasks to develop and maintain the approved supplier list.
• Conducts material and supplier risk assessments and periodic reviews of supplier performance.
• Coordinates and writes Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements.
• Provides input, guidance and recommendation for Supplier/Service Provider approval.
• Leads supplier certification activities.
• Provides support to the warehouse for incoming receipt, sampling and testing.
• Issues Complaints and Remarks to Suppliers (CARTs) and maintains the complaint database.
• Monitors and evaluates supplier change notifications.
• Provides input and guidance to continuous improvement initiatives in the materials management space as a material quality subject matter expert (SME).
• Performs materials SAP data steward functions.
• Authors, reviews and/or approves materials and other GMP documents, including specifications and procedures. Provides procedure ownership and subject matter expertise, as necessary.
• Provides the voice of quality to the Parenteral Supplier Committee, providing input and support as needed to ensure compliance.
• Supports regulatory inspection activities as needed by providing documentation and SME support.
• Tracks and reports materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.
• Leads, as required, local or global teams, committees or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.

• Works with the global and network materials management teams to benchmark and replicate best practices.

Basic Requirements:

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
• Minimum 5 years in the pharmaceutical industry with specific materials and supplier management experience.
• Fluent in English and German.
• On-site presence required.

Additional Skills/Preferences:

• Demonstrated understanding of cGMP regulations.
• Previous experience in GMP production environments.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing
• Proficiency with applicable computer systems including SAP, Trackwise, and Veeva
• Demonstrated strong oral and written communication skills
• Demonstrated interpersonal skills and the ability to work as a team
• Ability to influence externally with suppliers and resources across sites.
• Root cause analysis/troubleshooting skills
• Demonstrated attention to detail and ability to maintain quality systems
• Proven ability to work independently or as part of a Team to resolve an issue
• Technical Writing and Communication Skills
• Previous regulatory inspection readiness and inspection execution experience.

Additional Information:

• Primary location is Alzey, Germany
• Ability to travel (approximately 10-20 %)
• Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role
• Ability to work overtime as required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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