Associate Director, Supplier Quality Management

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: Associate Director, QMS – GXP Supplier Quality Management

The Associate Director, QMS – GXP Supplier Quality Management, ensures compliance with GXP (GMP, GCP, GLP, GVP, GDP) guidelines across all supplier and vendor relationships. This role is responsible for overseeing supplier quality activities, ensuring quality standards are met, managing supplier audits, and partnering with internal and external stakeholders to drive continuous improvement in the supplier quality management program. This role is also responsible for Esperion’s GXP Internal Audit program.

Preferred Location: Remote – US 

Essential Duties and Responsibilities*

Supplier Quality Management (SQM):

• Implement a robust and compliant risk based SQM program, systems and procedures to manage Esperion’s GXP vendors and service providers including quality/compliance oversight and conducting audits.
• Lead the supplier qualification, monitoring, and requalification processes, including risk assessments.
• Implement and oversee the improvement initiatives to enhance supplier performance and compliance.
• Track and trend key quality metrics related to supplier audits and report metrics during QMRs.

Audits and Compliance:

• Develop annual external and internal audit schedule.
• Plan and conduct/manage routine and for-cause audits of suppliers (e.g., raw material, contract manufacturing, contract testing labs). 
• Plan and conduct/manage internal GXP functional areas.
• Prepare detailed audit reports and ensure timely resolution of non-conformances and CAPAs (Corrective and Preventive Actions).
• Ensure all suppliers comply with Esperion expectation, internal procedures and regulatory requirements such as FDA, EMA, and other international health authorities.

Vendor Relationship Management:

• Serve as the primary point of contact for supplier quality issues.
• Support Quality team to investigate product quality complaints, quality events, incidents and CAPAs associated with Product(s) and/or services provided by the suppliers. 
• Collaborate with suppliers to drive continuous improvement and ensure delivery of high-quality materials and services.

Quality Systems and Documentation:

• Maintain accurate supplier records, including quality agreements, audit reports, questionnaires, etc.
• Work with internal QA teams to ensure timely documentation of supplier-related issues in Esperion’s Quality Management System (QMS).
• Negotiate and draft commercial quality technical agreements

Manage other QA responsibilities to support GxP functions, as assigned.

Qualifications (Education & Experience)