QA Advisor - Global Quality Systems

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.

About the job

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.

Responsibilities

The QA Advisor - Global Quality Systems will establish and maintain elements of Lilly's Quality Systems, which include Lilly Global Quality standards, business processes, implementation tools and the associate IT systems and applications.  The QA Advisor will be the Business Quality Assurance representative for several IT systems and applications supporting the QMS. They will also manage the process to distribute, collect and consolidate evaluations stemming from updates to existing or new regulatory documents.

The QA Advisor will consult with Lilly manufacturing facilities, external supplier organization, marketing affiliate quality operations, and other functions to educate on the quality system, and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends and scientific principles.

Key Objectives/Deliverables

The QA Advisor – Global Quality Systems is responsible:

• As Business Quality Assurance, represent business area requirements within the applicable IT systems and applications and influence the future direction of the applications.
• Support releases, implementation of new functionalities, evaluate changes, deviations and participate in validation activities of the applicable applications.
• Consult with site / global QA/QC/CSQ/IT teams to resolve related quality issues.
• Once new or updated regulatory documents are available, ensure they are sent for evaluation to the correct global SME’s.
• Ensure the evaluations are fully complete and consolidate evaluations where required, creating actions if needed.
• Develop, establish, and maintain Lilly global quality standards and provide education and training as necessary.
• Lead and/or support the assessment, development, and implementation of critical global projects in support of continual Global Quality System improvements.

Basic Requirements:

• 8+ years of direct experience in pharmaceutical setting.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Must have past experience in a Business Quality Assurance type role.

Additional Skills/Preferences:

• Demonstrated ability to interact with and support IT systems/tools that support quality processes.
• Ability to communicate and deliver constructive feedback to customers, including good oral, written and presentation communication skills.
• Strong knowledge of GXPs and quality management systems and how to evaluate against updates to regulatory documents.
• Experience writing standards, practices, policies, and/or procedural documents.
• Proficiency in planning and carrying out tasks with a great degree of independence and as part of a team, with minimal supervision.
• Prior experience with MetricStream, Trackwise, Veeva, JUMP, PLM would be beneficial.

Additional Information:

• Available to travel (domestic and international) when required.
• Fluent in English, additional languages are also recommended.
• Role may be based at selected Lilly Locations the US: Indianapolis, IN, Branchburg, NJ, Concord, NC, Research Triangle Park, NC.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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