Associate - Product R&D QA Clinical Trial Packaging - Collaboration Partner Oversight - Eli Lilly and Company

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Organization Overview:

Product Research and Development (PRD) Quality Assurance (QA) is responsible for providing quality oversight of all materials used in clinical trials.  PRD QA Clinical Trial (CT) Packaging is responsible for oversight of packaging and release of finished goods material within PRD and assures compliance with quality systems and current Good Manufacturing Practices (cGMP).  

Position Description:

The PRD QA CT Packaging Collaboration Partner Oversight role has the responsibility to manage all Collaboration Partner (CP) site qualification activities for global packaging operations and provide on-going Quality oversight to outsourced Clinical Trial Packaging activities.  The Packaging CP Oversight role is integral for ensuring GMP compliance at the CPs and providing leadership and support during person-in-plant activities, audits, technical transfers, and CP steering committee or quarterly business review meetings.  The Packaging CP Oversight role will also serve as a mentor and provide guidance to the Packaging QA team.

Key Objectives/Deliverables:

• Manage the qualification of new and current global Packaging and Labelling CPs according to applicable PRD Quality System (QS) standards.

• Participate in the creation or revision of relevant Quality standards both internally and at the CP, including development and implementation of strategic Lilly initiatives.

• Continually evaluate organization compliance and risk through monitoring of collaboration partner as well as Complaint, Deviation and Change metrics – and influence senior management to drive improvement of potential issues while proactively providing a solution.

• Author and maintain Quality Agreements with CPs and other Lilly sites and collaborators.

• Conduct periodic risk assessments and develop appropriate Quality Management Plans based on Quality indicators (data).

• Periodically present Quality status of CPs to internal and external management and business partners.

• Provide Quality leadership and support to CP partners during inspections, person-in-plant, or on-site visits.

• Originate, coordinate, or provide consultation on deviation investigations associated with CP processes.

• Track compliance to Quality Agreement requirements and Quality Plan action items.

• Act as mentor and provide guidance to Packaging QA team on CP related issues.

Basic Requirements:

• Bachelor's degree in science related field such as Pharmacy, Chemistry, Engineering, Biology, or related life sciences.

• Minimum 5 years of experience in a regulated manufacturing environment (preferably with packaging experience)

Additional Skills/Preferences:

• Possess technical understanding of cGMPs; ICH Guidelines; EU GMPS, general Quality systems and their application to clinical trial packaging.

• Deep understanding of the clinical trial materials supply chain.

• Demonstrated technical understanding of packaging.

• Demonstrated understanding of supplier/CP management and applicable requirements.

• Ability to lead and influence diverse groups and communicate effectively to all levels of an organization internally and externally.

• Ability to seamlessly balance multiple or potentially diverse projects/tasks while meeting commitments and deadlines.

• Demonstrated ability to evaluate and act quickly on potential issues.

• Ability to properly assess compliance, technical, and regulatory risks and initiate escalations when appropriate.

• Demonstrated ability to be self-driven, work independently, and have time management skills.

• Ability to provide consultation to internal or external business partners on clinical manufacturing, packaging, and labeling.

• Have strong written, verbal, and interpersonal communication skills.

• Ability to travel to CPs for on-site meetings, issue resolution, or serve as a person-in-plant.

Additional Information:

• Approximately 10% US and/or OUS travel required.

• This is an onsite position that requires onsite presence the majority of the time in Indianapolis, IN. This is not a remote role.

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