Representative-QA MMQA

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 Brand Description:

To provide support to the Indianapolis Device Assembly and Packaging (IDAP) materials management systems.  The Materials Management representative provides Quality Oversight for the suppliers and materials utilized by the IDAP Site.  This position supports all Materials Management activities relative to IDAP Products to ensure appropriate Quality Oversight.

Key Objectives / Deliverables:

• Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.
• Conduct material and supplier risk assessments and periodic reviews of supplier performance.
• Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements.
• Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.
• Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).
• Provide input and guidance to site activities (e.g. six sigma, new product / process development, change controls) as material quality SME.
• Be able to perform materials SAP data steward functions, if necessary.
• Review and Redline GMP documents, including specifications and procedures.  Provide procedure ownership and subject matter expertise, as necessary.
• Provide the voice of quality to the IDAP 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.
• Lead, as required, local or global teams, committees or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Requirements:

• Bachelor’s degree or equivalent experience in a science-related field.
• Minimum 2 years of relevant experience in a regulated environment

Additional Preferences:

• Experience with Lilly deviation and change control processes.
• Experience in material management, quality systems and cGMPs.
• Proficiency with current computer systems and applications including Microsoft Office products, SAP, EDMS and TrackWise or similar systems.
• Strong oral and written communication and interpersonal skills.
• Ability to influence externally with suppliers and resources across sites.

Other Information:

• Overtime may be required.

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

• Applicant may work in various areas within the IDAP Site.  Some allergens are present in the IDAP Site.
• Mobility requirements and exposure to allergens should be considered when applying for this position.
• This position is located in Indianapolis, IN and regular in person attendance is 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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