Senior Principal - Materials Management QA

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.

Materials Management and Quality Assurance Representative – Device Assembly and Packaging

Company Overview

Lilly, a leading innovation-driven corporation is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world’s most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!

Manufacturing and Quality Technical Hub Hyderabad

Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub. This hub will oversee the significant investment in contract manufacturing of starting materials and intermediates for API manufacturing in India and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of process engineering, chemistry, analytical and data sciences to build a cutting-edge scientific organization supporting the exciting manufacturing portfolio of Lilly.

Job Description

Role Overview:

This role provides 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 related to IDAP Products to ensure appropriate Quality Oversight

Key Responsibilities

• 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.
  
  
  

Minimum Experience

• Demonstrated relevant experience in a GMP facility.
• 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.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  
  
  

Additional Preferences

• Experience with Lilly deviation and change control processes.
• Experience in material management, quality systems and cGMPs
  
  
  

Education & Experience

• Bachelor’s degree or equivalent experience in a science-related field with 5 to 10 years of experience in a relative function.
  
  
  

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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