Sr. Associate/Principal Associate - External Manufacturing API Quality Assurance

Role Summary

The API EM Quality Associate provides support to all quality activities at Contract Manufacturing organizations (CMs) to ensure that all batches meet specifications, are manufactured in accordance with validated processes, and comply with cGMPs and regulatory commitments. The role involves daily interaction with external partner teams and site management to maintain quality across API manufacturing and shipments.

Responsibilities

• Serve as a quality liaison between CMs and Lilly.
• Provide quality oversight of CMs, acting as the initial point of contact for quality-related issues; escalate issues to Lilly QA management when needed.
• Assist in establishing and revising Quality Agreements with affiliates and customers; ensure compliance with Quality Agreements and MRDs.
• Provide quality oversight of Lilly/APIEM Quality Plans; coordinate and perform QA responsibilities of API shipments.
• Participate in regulatory inspection preparations with CMs and provide on-site support during inspections.
• Participate on the Technical Review Board; evaluate and disposition API batches as required.
• Ensure documented checks for Certificates of Testing and Environmental Monitoring are complete, and that deviations, changes, and batch documentation demonstrate requirements are met prior to batch release.
• Provide quality support of API manufacturing with a holistic review of activities affecting manufacturing processes, including deviations, change controls, and countermeasures.
• Assess the impact of deviation investigations and changes; ensure records are documented and retrievable; maintain state of control of processes.
• Maintain awareness of external regulatory findings referencing product quality; review and approve documents (procedures, MPRs, change control proposals, deviations, equipment qualifications, analytical methods, and validated computerized systems).
• Participate in APR activities and projects to improve productivity; participate in Joint Process (JPT) and Post Launch Optimization (PLOT) teams.

Qualifications

• Required: BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• Required: 5+ years of GMP manufacturing knowledge and/or experience in API or finished product manufacturing.
• Preferred: Experience in quality support for Quality Control activities; strong understanding of quality systems and regulatory requirements.
• Preferred: Knowledge of pharmaceutical manufacturing operations; coaching/mentoring skills; root cause analysis experience; statistical skills; strong written and verbal communication; attention to detail; proficiency with computer systems; ability to organize, prioritize, and influence diverse groups.

Skills

• Strong interpersonal and networking abilities; effective written and verbal communication.
• Ability to organize and prioritize multiple tasks; capacity to influence diverse groups and manage relationships.
• Proficiency with computer system applications; analytical and problem-solving skills.
• Attention to detail and commitment to quality and regulatory compliance.

Education

• BS in Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.

Additional Requirements

• Must complete required training for API EM Quality Assurance.
• Must be able to support 24 hour/day operations.
• This role is onsite in Indianapolis, IN and is not remote; relocation assistance will be provided.