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Lilly Consultant QA 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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism

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 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 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 Data Integrity SME is the quality expert for EMSA, actively leads in strategic planning and governance to strengthen the EMSA DI program, also is responsible for identifying gaps, the implementation of initiatives, and providing guidance to team.

Computer Systems (CS) QA SME

The CS QA is essential for understanding regulations, implementing and maintaining the systems, and ensuring inspection readiness. This includes the development, management, and continuous improvement of the EMSA CS quality system. The CS QA will ensure that quality systems are in place for EMSA and the CMs that they support and that they are compliant with regulatory requirements, global quality standards, cGMPs, and Quality Agreements.

Key Objectives/Deliverables:

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

  • Provide guidance and quality oversight of CMs manufacturing, packaging, the batch disposition process and maintenance/improvements of their quality systems

  • Evaluate issues, deviations, change controls and disposition batches countermeasures

  • Participate on Joint Process Teams

  • Originate and investigate deviations associated with batch records and other EMSA activities

  • Work with Lilly support groups to resolve product related issues

  • 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

  • Provide assistance and guidance in Standard Operating Procedure revisions, Master Batch Record revisions, Master Packaging Order revisions and Process Validations

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

  • Author and track compliance to the CM Quality Agreements and CM Quality Plans

  • Routinely have 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

  • Provide support for Notification to Management data gathering

  • Provide input for metrics reports to management

  • Establish, maintain, improve, and monitor effectiveness of EMSA Data integrity program

  • Ensure compliance to DI guidelines

  • Develop local DI procedures and continually evaluate, maintain, and improve DI program

  • Establish, maintain, improve, and monitor effectiveness of EMSA CS program

  • Ensure compliance to CS guidelines

  • Develop local CS procedures and continually evaluate, maintain, and improve DI program

  • Complete other duties as assigned

Basic Requirements:

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

Additional Skills/Preferences:

  • Technical understanding of cGMPs and the Global 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

  • Previous pharmaceutical manufacturing or quality experience

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

  • Experience with Lilly electronic systems (SAP, Trackwise, Regulus) and computer system validation.

  • Experience with DI for drug product manufacturing and packaging processes

  • Ability to conduct GMP activities in both English and Spanish (read, write, & speak)

  • Experience developing and maintaining specification systems for raw materials, components, drug product, and finished product

  • At least 5 years’ experience directly supporting a manufacturing and packaging operations

  • Proficiency in leading root cause investigations and self-inspections

  • Project management skills

  • Coaching and mentoring skills

Other Information:

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

  • Travel is possible, 10 – 25%

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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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