Sr. Associate/Principal Associate - Supplier Quality Management - QA - Manufacturing Logistics

Lilly • Indianapolis, IN • 1d ago

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.

We are seeking an experienced quality associate to manage the Supplier Quality Management program for the Manufacturing Logistics organization. This role will be responsible for ensuring the onboarding, qualification and ongoing maintenance of the third-party logistics providers of warehousing and storage services.

The Sr. Associate / Principal Associate / Sr. Principal Associate - SQM- QA is a Quality professional with expertise in supplier relationships, GMP quality assurance, and distribution compliance. The position ensures the application of GMP and Lilly corporate standards in the supplier management program on behalf of the Manufacturing Logistics QA organization.

Key Responsibilities:

Maintain Supplier and GMP Service Provider Management Data in SAP to keep the Manufacturing Logistics Approved Supplier/Service Provider List current.

Perform Periodic Performance Evaluations (PPE) reviews.

Support internal audits and external inspections: maintain systems to support inspections.

Ensure local program procedures are in compliance with global requirements and communicate any gaps to QA management, including generation of site audit documentation (e.g. Audit Delay Memos, No Audit Justification, etc.) and local risk assessments, as necessary.

Exhibit cross-functional and multi-site influence providing guidance and interpretation of program requirements for Manufacturing Logistics.

Generate and support deviations and change control records related to Supplier Management and GMP Service Provider program.

Develop and approve, as applicable, Quality Agreements and Supplier Material Requirements Documents (SMRDs) with high/medium risk per related CQPs for GMP Service Providers.

Monitor completion of vendor complaints and remarks.

Provide monthly metrics of the Supplier Quality Management Program to QA management.

Ensure internal and external quality and supply commitments are met.

Complete or revise Material and Overall Risk Assessments (MORs) and Supplier Risk Assessments (SRAs) as needed for program compliance.

Review the Annual Product Review (APR) for material sections, as necessary.

Provide oversight and review of changes to the Global Quality Standards and procedures and ensure local implementation of changes.

Provide support for Certified/Preferred Suppliers to ensure compliance with global standards.

Basic Qualifications:

BS or equivalent in a scientific field or engineering.

5+ years in pharmaceutical, quality, and compliance roles.

Knowledge of cGMPs and quality systems.

Additional Preferences:

Strong candidates for the role will have many or all of the following:

Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs.

Demonstrated strong written and verbal communications skills.

Strong attention to detail.

Understanding of statistical tools and analysis.

Excellent interpersonal skills and networking skills.

Ability to organize and prioritize multiple tasks.

Demonstrated strong problem solving and analytical thinking skills.

Demonstrated project management skills.

Demonstrated understanding of computer system applications.

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

$63,000 - $162,800

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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