Senior QA Lead – API Manufacturing & External Partners

Eli Lilly and Company; Kinsale; On-site; EUR 56,000 - 146,000; Full time

Benefits offered by this job

401(k) plan

Vacation benefits

Medical/dental/vision benefits

Job summary

Eli Lilly and Company is seeking a Quality Assurance professional to oversee API manufacturing quality across contract manufacturers. The role requires coordinating QA activities, ensuring compliance with Quality Agreements and MRDs, and supporting regulatory inspections.

The candidate will provide quality oversight for API shipments, participate in process improvements, and contribute to cross-functional teams to maintain state-of-control processes.

Qualifications

• Bachelor's degree in a science-related field.
• At least 2 years GMP manufacturing experience in API or Pharma (finished product, QC, QA or Engineering).
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas.

Responsibilities

• Serve as a liaison between CMs and Lilly.
• Provide quality oversight of Contract Manufacturers (CMs) and act as initial contact for quality issues.
• Escalate quality issues to Lilly QA management.
• Assist in establishing and revising Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and MRDs.
• Coordinate QA oversight of Lilly/APIEM Quality Plans.
• Oversee QA responsibilities for API shipments from suppliers and CMs.
• Participate in regulatory inspection preparations and provide on-site support.

Skills

Quality oversight

Regulatory compliance

QA systems

Root cause analysis

Statistical skills

Coaching skills

Process documentation

Education

Bachelor's degree in a science-related field

Job description

Eli Lilly and Company is seeking a Quality Assurance professional to oversee API manufacturing quality across contract manufacturers. The role requires coordinating QA activities, ensuring compliance with Quality Agreements and MRDs, and supporting regulatory inspections.

The candidate will provide quality oversight for API shipments, participate in process improvements, and contribute to cross-functional teams to maintain state-of-control processes.