Senior Global QA Lead – GLP & Audits

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

Job summary

Merck's Research and Development Quality Assurance (QA) organization provides quality focus at each stage of the product development life cycle, including post approval activities, to ensure high‑quality, safe, and effective products. Our QA team oversees GLP programs and collaborates across domestic and international sites to uphold regulatory standards and drive continuous improvement.

The role involves leading GLP QA audits, ensuring compliance with FDA GLPs and OECD guidelines, and

Qualifications

• Experience conducting GLP audits.
• Familiarity with FDA GLPs and OECD guidelines.
• Ability to collaborate with global sites and contract facilities.

Responsibilities

• Facilitates communication and alignment with key stakeholders upstream and downstream.
• Conducts GLP audits in accordance with QA risk-based processes and company policies and guidelines.
• Serves as a Lead Liaison for QA activities at company sites and contract facilities worldwide.
• Provides expert knowledge of assigned QA project areas and manages daily activities, including prioritizing, planning, and scheduling.

Skills

GLP auditing

QA oversight

Regulatory compliance

Stakeholder communication

Job description

Merck's Research and Development Quality Assurance (QA) organization provides quality focus at each stage of the product development life cycle, including post approval activities, to ensure high‑quality, safe, and effective products. Our QA team oversees GLP programs and collaborates across domestic and international sites to uphold regulatory standards and drive continuous improvement.

The role involves leading GLP QA audits, ensuring compliance with FDA GLPs and OECD guidelines, and