Senior / Principal Associate QA API External Manufacturing

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, focused on discovering and delivering life‑changing medicines while improving disease understanding and providing community support through philanthropy and volunteerism.

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• Serve as a liaison between contract manufacturing organizations (CMs) and Lilly.
  
• Provide initial quality oversight of CMs and be the primary point of contact for all quality‑related issues.
  
• Escalate CMs quality issues to Lilly QA management.
  
• Assist in establishing and revising Quality Agreements with affiliates and customers.
  
• Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
  
• Provide quality oversight of Lilly/API‑EM Quality Plans and coordinate QA responsibilities for API shipments.
  
• Participate in regulatory inspection preparations with CMs and offer on‑site support during inspections.
  
• Participate on the Technical Review Board and evaluate and disposition API batches as required.
  
• Verify that documented checks (Certificates of Testing, Certificates of Environmental Monitoring, deviations, changes, batch documentation) have been completed prior to batch release.
  
• Offer quality support for API manufacturing, focusing on holistic review of key activities such as deviations, change controls, and countermeasures.
  
• Assess the impact of deviation investigations and changes, ensuring all records are documented and retrievable.
  
• Maintain all processes in an appropriate state of control.
  
• Stay informed of external regulatory agency findings related to product quality.
  
• Review and approve documents such as procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
  
• Participate in Annual Product Review (APR) activities.
  
• Engage in projects to improve productivity.
  
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) teams.
  

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• Bachelor’s degree in Pharmacy, Chemistry, Biological Sciences, or a related Life Sciences field.
  
• Five or more years of GMP manufacturing knowledge and/or experience in API or finished product manufacturing and QA.
  

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• Experience in quality support for Quality Control activities.
  
• Thorough technical understanding of quality systems and regulatory requirements.
  
• Knowledge of pharmaceutical manufacturing operations.
  
• Demonstrated coaching and mentoring skills.
  
• Experience in root cause analysis.
  
• Application of statistical skills.
  
• Strong written and verbal communication skills.
  
• Attention to detail.
  
• Proficiency with computer system applications.
  
• Excellent interpersonal and networking skills.
  
• Ability to organize and prioritize multiple tasks.
  
• Ability to influence diverse groups and manage relationships.
  

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• Must complete required training for API EM Quality Assurance.
  
• No certifications required.
  
• Must be able to support 24‑hour/day operations.
  

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage range for this position is $65,250 - $169,400.

Lilly offers a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible spending accounts, life insurance, leave of absence options, and well‑being benefits such as an employee assistance program and fitness benefits.

Lilly is proud to be an Equal Employment Opportunity 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 members and are open to all employees. 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), and enAble (for people with disabilities).

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