Manager, Product Quality

Responsibilities

• Serve as Product Quality Lead for assigned program(s).
• Investigate and finalize reporting activities for potential product complaints
• Support Clinical Operations as required in the evaluation of product temperature excursions
• Support manufacturing campaigns and release activities.
• Ensure archival for expedient retrieval of key manufacturing documentation
• Review deviations, investigations, CAPAs, and change controls for adequacy.
• Analyze and report on product quality trends
• Facilitate the development of risk assessments and mitigation activities and perform routine risk monitoring activities.
• Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions.
• Support inspections and audits.
• Basic Requirements:
• BS/MS in Life Sciences.
• 5-10 years pharmaceutical quality experience.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
• Knowledge of GMP manufacturing and quality systems.
• Additional Preferences:
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn’t clear.
• Leverage technical depth and a growth mindset to make impact; imagine what’s possible and pursue it with intention and energy.
• Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.
• 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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
• Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
• $66,000 - $169,400
• 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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