Manager, Product Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Product Quality Lead for designated program(s)

• Investigate and complete reporting tasks for potential product complaints

• Assist Clinical Operations in assessing product temperature deviations

• Support manufacturing campaigns and product release processes

• Ensure proper archival for quick access to essential manufacturing documents

• Evaluate deviations, investigations, CAPAs, and change controls for effectiveness

• Analyze and provide reports on product quality trends

• Facilitate the creation of risk assessments and mitigation strategies

• Conduct routine risk monitoring activities

• Collaborate with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to aid regulatory submissions

• Provide support during inspections and audits

⛳️ Requirements

• BS/MS in Life Sciences

• 5-10 years of experience in pharmaceutical quality

• Eligible candidates must be authorized to work in the United States on a full-time basis

• Lilly will not assist with or sponsor work authorization or visas for this position

• Familiarity with GMP manufacturing and quality systems

• Capable problem solver

• Possess technical expertise and a growth-oriented mindset

• Demonstrated curiosity and initiative for self-directed innovation, particularly in artificial intelligence and digital technologies

🏝️ Benefits

• Company bonus based on both company and individual performance

• Company-sponsored 401(k)

• Pension plan

• Vacation benefits

• Medical coverage

• Dental coverage

• Vision coverage

• Prescription drug coverage

• Healthcare and/or dependent daycare flexible spending accounts

• Life insurance and death benefits

• Time off and leave of absence benefits

• Employee assistance program

• Fitness benefits

• Employee clubs and activities