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Lilly Quality Lead, External manufacture and Supply Americas (EMSA) in Indianapolis, Indiana

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 35,000 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.

Position Brand Description:

External Manufacturing and Supply - Americas (EMSA) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North, and South American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. EMSA Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The QA Lead for Contract Manufacturers (CMs) provides daily oversight, assistance, and guidance to issues such as deviation investigations, change control proposals, procedure/ master formula revisions, validations and other duties associated with daily CM activities. This role provides and assures compliance to Lilly Global Quality Standards (GQS) by resolving identified procedural gaps and is responsible for assuring the CM maintains a state of control with regards to manufacturing and/or packaging product. The QA Lead is integral for maintaining GMP compliance and providing support during preparations for Pre-Approval/ General inspections by various agencies. The QA Lead is integral for launching new products, packages, processes, and CM's.

The Associate Consultant QA is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements

Key Objectives/Deliverables:

  • Lead/ provide support to launch new products/ packages/ CMs

  • Provide guidance and quality oversight of manufacturing issues, deviations, change controls and countermeasures

  • Responsible for developing the Quality agreement between EMSA and external partner and assure compliance with it.

  • Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols, complaints), as applicable

  • Make sure product and sterility assurance control strategy in place and appropriate

  • Participate on Joint Process Teams

  • Originate and investigate deviations

  • Work with Lilly support groups to resolve product related issues

  • Participate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging Orders

  • Perform batch record review and product release to market.

  • Provide final approval of Certificates of Analysis or other similar documentation for internal and external customers

  • Provide support on site or remotely during inspections and maintain awareness of internal audit findings and external regulatory agency inspections

  • Author and track compliance to CM Quality Plan

  • Routinely have virtual and face-to-face communications with CMs

  • Track and monitor Quality metrics for trends at the CM

  • Support Qualifications/ Validation document creation and reviews

  • Provide and coordinate designated sections for Annual Reports and Annual Product Reviews

  • Execute SOP assessments of CMs and track completion of outstanding issues

  • Support CMs effort to maintain and improve their quality systems

  • Contribute to Quality culture efforts at both EMSA and CM

  • Complete other duties as assigned

Basic Requirements:

  • At least 5 years previous pharmaceutical manufacturing or quality experience

Additional Preferences:

  • Proven ability to work independently or as part of a Team to problem solve

  • Experience with Pharma industry electronic systems (SAP, Trackwise, Regulus)

  • Project management skills

  • Previous experience in Sterility assurance, EM and visual inspection

  • Previous experience with batch disposition for drug product manufacturing and packaging processes

  • Coaching and mentoring skills

  • Technical understanding of international cGMPs (e.g., FDA, EU, Japan) and the Pharmaceutical Industry Quality Standards

  • Knowledge of Pharmaceutical Manufacturing Operations

  • Strong written and verbal communication skills

  • Teamwork and interpersonal skills exhibited across functional areas

  • Ability to organize, prioritize, multi-task, and influence diverse groups

  • Strong decision making and problem solving skills

Education:

Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience

Other Information:

  • Shift days, but off-hours may be necessary to support operations

  • Travel is possible, up to 30%

Lilly is an EEO/Affirmative Action Employer and 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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