Quality Assurance Associate - Drug Product External Manufacturing

Role Summary

Quality Assurance Associate – Drug Product External Manufacturing (DPEM) provides daily oversight, guidance, and quality assurance support for contractor manufacturers across North, Central, and South America. The role ensures GMP compliance, supports deviations, change controls, validations, and supplier quality activities, and contributes to inspections and launches of new products, packages, and CM partnerships.

Responsibilities

• Lead and provide support to launch new products, packages, and contract manufacturers (CMs).
• Participate on Joint Process Teams and monitor CM processes for regulatory compliance.
• Review and approve event investigations and change controls.
• Collaborate with Lilly support groups and subject matter experts to resolve product-related issues.
• Contribute to creation and revision of standard operating procedures.
• Participate in Six Sigma projects to improve productivity.
• Provide on-site or remote support during inspections.
• Prepare and track compliance to CM Quality Agreements and CM Quality Plans.
• Ensure CMs follow quality systems; conduct regular visits and communications to monitor performance.
• Maintain face-to-face communications with CMs and monitor quality metrics for trends.
• Support qualifications/validation document creation and reviews.
• Coordinate sections for Annual Reports and Annual Product Reviews; execute SOP assessments of CMs.
• Support CMs in maintaining and improving their quality systems; provide technical leadership and project management oversight.
• Maintain regular communication with external manufacturers and report progress to DPEM Management; respond to information requests.
• Benchmark with other Lilly sites and network with external partners to share best practices.
• Support batch release activities by reviewing documentation for final disposition.

Qualifications

• Basic Qualifications: Bachelor’s Degree in Pharmacy, Chemistry, Biological Science or other relevant field.
• 5+ years of parenteral product manufacturing and quality experience.

Skills

• Knowledge of Pharmaceutical Manufacturing Operations.
• Strong written and communication skills; attention to detail in procedures and protocol development.
• High learning agility; strong leadership, interpersonal, and teamwork skills.
• Ability to organize, prioritize, multi-task, and influence others; strong decision-making and problem-solving abilities.
• Willingness to learn new technologies; ability to work in virtual and complex environments.
• Proven ability to work independently or in a team; regulatory-related experience.
• Established technical, quality, and internal networks; experience with Lilly systems (SAP, TrackWise, Q docs, etc.).
• Preferred: minimum 5 years of experience supporting manufacturing.

Education

• Bachelor’s Degree in Pharmacy, Chemistry, Biological Science or other relevant field

Additional Requirements

• Shift is days, but off-hours may be necessary to support operations.
• Travel up to 30%.