QA for QC - Drug Product External Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities

The QA for QC employee for Drug Product External Manufacturing (DPEM) provides quality laboratory oversight, assistance, and initial guidance to issues such as non-conformance investigations, change control proposals, method transfers, specification development and maintenance, validations, and other duties associated with daily laboratory activities occurring at our contract external manufacturing organizations (CMs). This role provides and assures compliance to established quality policies by resolving identified procedural gaps and works within the Lilly Joint Process Team (JPT) to assure the CM maintains a state of control with regards to laboratories.

The QA for QC employee is integral for maintaining GMP compliance, providing support as applicable during preparations for pre-approval/general inspections by various agencies, and launching new products, processes, and CMs.

A specific focus for this role is Laboratory Primary Loop activities, which provides oversight, assistance, and guidance to CMs and other DPEM team members for lab activities.

Key Objectives/Deliverables:

* Be the conduit. Build and maintain strong working relationships with key CM personnel in addition to partnering with the JPT to ensure the laboratory function at the CM operates with excellence and supports the operational control strategy. This requires routine face-to-face communications with both JPT and CM.

* Provide initial consultative guidance and quality oversight of laboratory issues, OOS investigations, deviations, change controls and counter measures to both Lilly JPT and the CM.

* Partner with the broader Lilly network to leverage depth of technical expertise at Lilly in order to resolve product related issues.

* Provide technical leadership and project management oversight to drive improvements to CM lab quality systems. Further support CMs efforts to maintain and improve their quality systems, including consulting with CM labs to understand Lilly laboratory quality requirements.

* Provide support to DPEM QA/QC Secondary Loop personnel to support commercial launch activities surrounding new products/ packages/ CMs.

* Some specific responsibilities which this role is responsible for owning, include:

* Input/verify CM laboratory data within supporting systems (e.g., DARWIN/LIMS) to create CoAs in support of batch release activities. Provide CoA support for both internal and external customers.

* Coordinate the supply of reference standards to CM labs, as applicable.

* Support/oversee implementation of analytical method and specification and change request for labs supporting final product release testing.

* Change control owner and execution for analytical/specification updates, protocol revisions, and continuous improvement projects within DPEM.

* Provide and coordinate designated sections including trend analysis of analytical data for Annual Reports and Annual Product Reviews.

* Own the DPEM stability program for your CM, ensuring all annual/validation stability commitments are met, up to and including active data trending of CM data.

* Review/approve laboratory GMP documents, including testing methods, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, and associated reports to align with Quality Agreement requirements and drive improvements through the lens of aligning with Lilly quality standards, where possible.

* Execute SOP assessments of CMs and track completion of outstanding issues.

* Advise DPEM QA…