QA Lead, API External Manufacturing

Eli Lilly and Company; Prince Edward Island; Hybrid; CAD 70,000 - 85,000; Full time

Job summary

A leading global healthcare company is seeking an API EM Quality Assurance Associate based in Prince Edward Island, Canada. The role involves ensuring all batches meet specifications and comply with regulatory commitments. Candidates must have a Bachelor’s in a relevant science field and possess GMP manufacturing experience. Skills in quality oversight, communication, and the ability to influence diverse groups are essential. The position requires onsite work three days a week and some travel to Indianapolis, Indiana.

Qualifications

• Bachelor’s of Science in Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.

Responsibilities

• Serve as a liaison between CMs and Lilly.
• Provide quality oversight of CMs.
• Escalate quality issues at CMs to Lilly QA management.
• Participate in regulatory inspection preparations.
• Evaluate and disposition API batches.

Skills

GMP manufacturing knowledge

Coaching and mentoring

Root cause analysis

Statistical skills

Communication skills

Attention to detail

Organizational skills

Interpersonal skills

Education

Bachelor’s of Science in a science-related field

Tools

Computer system applications

Job description

A leading global healthcare company is seeking an API EM Quality Assurance Associate based in Prince Edward Island, Canada. The role involves ensuring all batches meet specifications and comply with regulatory commitments. Candidates must have a Bachelor’s in a relevant science field and possess GMP manufacturing experience. Skills in quality oversight, communication, and the ability to influence diverse groups are essential. The position requires onsite work three days a week and some travel to Indianapolis, Indiana.