Associate Director, External QA & Vendor Oversight

Merck; West Point (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Merck is seeking an experienced Quality Assurance professional to oversee external entities and CMOs for clinical finished goods. You will lead investigations, drive data-driven quality improvements, and ensure regulatory compliance across the vendor network.

In this role, you will collaborate with R&D, Procurement, and Quality Disposition to align contractor performance with Merck standards, develop metrics, and mentor cross-functional teams in a matrix environment.

Qualifications

• Lead Quality Liaison for Quality Oversight of External Entities/CMOs.
• Oversee Third-Party Vendor quality in Clinical Finished Goods Platform.
• Lead investigations, review deviations, and negotiate quality agreements.

Responsibilities

• Serve as SME for significant quality events involving external contractors.
• Approve and assess CMO quality events, audit CAPs, and change controls.
• Support Clinical Supply Chain for quality and regulatory compliance of clinical supplies.

Skills

Quality Assurance

GMP

Regulatory compliance

Quality oversight

Vendor management

Issue investigation

Cross-functional leadership

Contractor relationship management

Data integrity

Tools

GMP audits

CAPA processes

Change controls

Job description

Merck is seeking an experienced Quality Assurance professional to oversee external entities and CMOs for clinical finished goods. You will lead investigations, drive data-driven quality improvements, and ensure regulatory compliance across the vendor network.

In this role, you will collaborate with R&D, Procurement, and Quality Disposition to align contractor performance with Merck standards, develop metrics, and mentor cross-functional teams in a matrix environment.