Quality Materials Management Specialist

Industry:

Company: Eli Lilly and Company

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.

Key Objectives/Deliverables

• Establish and maintain site the supplier quality management program in partnership with other Lilly manufacturing sites and global.

• Conduct material and supplier risk assessments and classifications for materials and supply chain participants where required.

• Formally approve or reject material or supply chain participant as appropriate based on assessment/classification result.

• Conduct periodic reviews of supplier performance, formally approve or reject material or supply chain participant as appropriate based on result of periodic review.

• Conduct or ensure that initial and ongoing supplier quality management activities take place as needed, these include but are not necessarily limited to:

• Initiation and review of supplier questionnaires

• Quality audits take place in accordance with Global requirements

• Initiation, review and updating of Quality Agreements

• Coordinate the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.

• Supplier Quality Management related activities and transactions within SAP and Trackwise

• Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.

• Responsible for materials and supplier complaint handling

• Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).

• Provide the voice of quality to the Parenteral Supplier Committee, providing input and support as needed in order to ensure compliance.

• Support regulatory inspection activities as needed by providing documentation and SME support.

• Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.

• Work with global resources, as necessary, to achieve compliance with requirements.

Minimum Requirements:

• Bachelors’ Degree or equivalent experience in a science – related field
• 2+ years demonstrated relevant experience in a GMP facility

• Proficiency with current computer systems and applications including Microsoft Office products, LMS, EDMS and TrackWise, MasterControl or similar systems

• Strong oral and written communication and interpersonal skills

• Ability to influence externally with suppliers and resources across sites

• Demonstrated technical writing skills.
• Experience in material management, quality systems and cGMPs

Other Information:

• Overtime may be required.

• May be required to respond to operational issues outside of core business hours and days.

• Position may require travel (10%)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly