Senior QA Associate - Materials & Vendor Management

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.
** Organization Overview:
** Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities.  This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

The Lebanon QA for Materials and Vendor Management provides daily oversight, assistance, and mentorship to material issues such as quality non-conformance investigations, change control proposals, vendor nomination and qualification, and life cycle management activities of vendors. This position is critical for maintaining GMP compliance and providing support during preparation for Pre-Approval and General Inspections by various regulatory agencies.

Main Purpose and Objectives of Position:
* Provide Quality leadership, direction, and governance for the specific areas of responsibility.
* Manage quality-related matters specific to area of responsibility.
* Responsible for approving appropriate quality-related documents.
* Promote and encourage Quality culture and promptly report any compliance concerns.
* Responsible for the qualification and monitoring of suppliers and service providers for the site
** Responsibilities:
*** Review and approval of key GMP documents
* Support Consumables, Raw Materials and Service providers (SP) liaising with cross functional teams (procurement, engineering, TSMS and supply chain), defining and risk assessing the supply chain and ensuring relevant documentation is shared.
* Responsible for Quality agreement generation and periodic reviews.
* Responsible for assessment and closure of Supplier Change Notifications.
* Assists in scheduling of local, national and international audits.
* Ensure all vendor files content is current and appropriately documented.
* Monitor and modify the supplier evaluation process as required.
* Participate in the new item code process and approve materials for use in PV/production
* Re-evaluation of vendors where required by SOP or driven by performance issues (complaints management)
* Review and approval of change controls, observations/ deviations
* Contribute to the Annual Product Reviews from a Vendor management perspective.
* Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
* Evaluation and contribution of regulatory information to regulatory documents
* Monitoring of GMP compliance, GMP programs including data integrity and systems by ensuring a regular presence the area of responsibility
* Participation in the Site Self-Inspection program global standards, policies, guidelines and procedures.
* Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
* Proactively engaged in Supplier Qualification Management metrics, timely completion of training and GMP records.
* Support QA incoming functions at multiple warehouse locations and tank farm/solvent recovery.
* Performing incoming inspections (raw materials, components, printed packaging materials, etc.) according to priority.
** Basic Requirements
*** Bachelor's degree in Pharmacy, Chemistry, Engineering, Quality, or related discipline
* 5+ years relevant experience in Materials and/or Vendor Management, Vendor Audits, etc.
* Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
** Additional Preferences
*** 2+ years of experience in tank farm/solvent recovery
* Excellent attention to detail.
* Experience working in cross functional teams and proven ability in decision making.
* Strong organizational skills, including ability to follow assignments through to completion.
* Understanding of Materials and Vendor Management and its applications
* Self-motivated, positive and ability to work under pressure.
* Excellent interpersonal and communication skills (written and oral).
* Demonstrates a continuous…