• Quality Assurance Associate Director (M2)

    Lilly (Branchburg, NJ)


    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.

     

    Eli Lilly and Company seeks a Quality Assurance Associate Director (M2) to provide quality direction for complex day¬ to-day quality activities and technical challenges ensuring GMP compliance. Partner with the business to resolve critical and complex compliance issues, remove barriers as they arise, and oversee data integrity for paper based and electronic systems, including quality review of audit trail reviews. Oversee the implementation of risk-based strategies. Ensure data compiled are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management. Prepare laboratories for regulatory inspections, support regulatory and business partner inspections/audits, and coordinate inspection/audit responses and commitments. Monitor workload for staff and re¬ prioritize as needed to ensure completion of all tasks. #LI-DNI

     

    Position requires a Bachelor's degree in Chemistry, Biology, Computer Science, or a related STEM field followed by 5 years of progressively responsible experience with quality assurance or quality control in the pharmaceutical or biopharmaceutical industry. Experience must include a minimum of: 5 years of technical experience in a GMP-regulated environment; 5 years of experience promoting data integrity and compliance; 5 years of experience with applying knowledge of computer systems validation per cGMPs and System/Software Development Lifecycle concepts; 5 years of experience providing oversight on contract lab operations, reviewing laboratory results, and ensuring samples meet testing acceptance criteria and regulatory limits; 5 years of experience leading operational excellence initiatives; 5 years of experience providing guidance on Data Life cycle Management; and 5 years of experience with Microsoft applications and quality systems. Up to 5% domestic and international travel required. #LI-DNI

     

    JOB LOCATION: Branchburg, NJ.

     

    To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-88222 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.

     

    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

     

    $184,080 - $189,072

     

    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.

     

    \#WeAreLilly