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.

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

$96,000 - $162,800

Responsibilities

The AQCO QA Representative ensures laboratory activities conducted by AQCO areas or Contract Laboratories are carried out in accordance with GQS quality standards and follow current Good Manufacturing Practice (cGMP). The individual will have quality assurance responsibilities and oversight for all aspects of AQCO operations (e.g., deviations, analytical investigations, change controls, equipment qualifications, computer systems validation, method validation, transfer protocols and summary reports).

Additionally, the QA Representative is responsible for working with AQCO leadership and cross-functional teams to define and execute AQCO projects, and support infrastructure activities.  The Principal Associate is expected to have knowledge and skills necessary to successfully lead AQCO through complex projects where resource management and capacity analyses are required.  The Principal Associate must possess product knowledge, leadership, business acumen, and demonstrated project management skills.  The Principal Associate must have strong relationship and communication skills and an ability to influence team members, leadership, and cross-functional teams.

Key Objectives/Deliverables:

The responsibilities for this position include:

Provide QA oversight for AQCO, contract laboratories and GMP Service Providers used by AQCO, as required.Ensure that appropriate Quality Systems are in place and in a state of compliance.Facilitate quality improvement initiatives and the implementation of new AQCO procedures.When necessary, evaluate potential impact of deviations on product quality of materials, or the integrity of data.Ensure appropriate investigations are conducted for analytical investigations, deviations, and out of specification (OOS) results. Review and approve the corresponding documentation.Lead the Change Control board and Deviation board.Perform Quality Assurance review and/or approval / rejection of GMP documentation and ensure that review/approval by appropriate technical experts has occurred. (e.g. method transfer protocols, validation summary reports)Provide quality oversight to ensure compliance with internal standards, procedures, and applicable regulations by maintaining a regular presence in AQCO areas and perform internal audits, as scheduled.Coordinate project-related business with other Lilly functions and sites.Lead global projects that interface between AQCO and sites as assigned.Execute projects in support of AQCO as assigned.Provide technical input and contribute directly to project implementation tasks as needed.Assemble metrics in support of quarterly Quality Lead Team meeting and annual Management Reviews.Member of AQCO Quality Lead Team

Basic Qualifications

Education: BS or MS, in field of Chemistry, Biology, Biochemistry, Pharmacy or Pharmaceutical Science.Experience:10+ years of experience in the pharmaceutical industry.Knowledge of analytical testing practices, cGMPs, quality systems, and other regulatory requirements.

Additional Skills/ Preferences

TrackWise proficiencyThorough technical understanding of the quality systems and regulatory requirementsProficiency with or Understanding of Computer System Standards and PracticesCSQA certified/qualifiedManufacturing Site experienceKnowledge of or proficiency in laboratory activities related to the product life cycle (i.e. product development through commercialization and implementation in Quality Control laboratories)Analytical equipment qualification experienceExperienced in Root Cause AnalysisDemonstrated ability to communicate and deliver constructive feedback to customers, including good oral, written and presentation skills.Proficiency in planning and carrying out tasks with a great degree of independence and as part of a team, with minimal supervision.Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.

Additional Information

The primary location for this position is Lilly Technology Center-North.This position may involve occasional travel (0-10%).

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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