Manager, GMP Quality Assurance, API

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.

Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Manager, GMP Quality Assurance, API

This position reports to the Associate Director, GMP Quality Assurance, API.

Preferred Location: Remote – US

Essential Duties and Responsibilities*

• Assist Active Pharmaceutical Ingredient (API) and Drug Product (DP) site Quality Assurance (QM) leads with batch record reviews and product release.
• Liaise with suppliers to resolve quality issues.
• Conduct quality review and approval of critical quality API and DP documents, including but not limited to batch records, deviations, corrective actions and preventive actions (CAPAs), change controls, complaints, specifications, stability protocols and reports, and Annual Product Reviews (APR).
• Assist QM site leads with supplier qualifications (by paper and/or physical audits), establishing/monitoring compliance to quality agreements, utilizing quality metrics to track supplier performance, as well as attending and on occasion leading Quality meetings with suppliers.
• Assist in the development and review of quality agreements with key suppliers.
• Excel as a backup for QM site leads in providing quality oversite of API and DP suppliers.
• Assist in the preparation and conduct of regulatory agency inspections.
• Participate in companywide quality systems continual improvement programs.
• additional duties and responsibilities as assigned

Qualifications (Education & Experience)

• Bachelor's degree in life sciences or closely related field from accredited college or university.
• Minimum 5 years of related work experience in Quality Assurance/Quality Management of drug development and commercial manufacturing within the pharmaceutical or biotechnology industry; or equivalent education and experience.
• Demonstrated working knowledge of FDA, EU, and ICH Regulatory requirements and guidelines specific to the areas of API and DP quality.
• Intermediate to advanced experience with MS Office software required.
• Experience with Veeva QMS preferred.
• Excellent written and oral English Communication skills.