Principal/Sr. Associate-QA-API External Manufacturing

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  The API EM Quality Assurance Consultant provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Consultant’s position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Key Objectives/Deliverables: Serve as a liaison between CMs and Lilly. Provide quality oversight of CMs including being the initial point of contact for all quality-related issues. Escalate quality issues at CMs to Lilly QA management. Assist in the establishment and revisions of Quality Agreements with affiliates and customers. Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs). Provide quality oversight of Lilly/APIEM Quality Plans Coordinate and perform QA responsibilities of API shipments from suppliers and CMs. Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections. Participate on the Technical Review Board Evaluate and disposition API batches, if required. Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release. Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures. Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable. Ensure all processes are in an appropriate state of control. Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product. Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations. Participate in APR activities. Participate in projects to improve productivity. Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.

Bachelors degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences. At least 2 years previous GMP manufacturing experience in API or Pharma experience in finished product manufacturing, QC, QA or Engineering. 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. Additional Preferences: 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. Demonstrated application of statistical skills. Demonstrated strong written and verbal communications skills. Strong attention to detail. Proficiency with computer system applications. Excellent interpersonal