Associate Director, Quality Assurance

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

Job Description

Our Research and Development division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high‑quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world.

Job Description

Our Research and Development division Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high‑quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research Quality (RQ) encompasses several functional quality groups who focus on technology and systems, suppliers, and internal processes. The functions perform both proactive quality oversight activities and auditing and provide support to strategic initiatives across our Research and Development division. The Good Laboratory Practice (GLP) team provides independent quality oversight assuring that the company’s non -clinical studies and internal clinical analyses are conducted in compliance with regulatory expectations. Essential functions include but are not limited to in partnership with GLP QA Functional and Operation Leads, support the implementation and management of the QA strategy. Independently facilitates specific tasks in compliance with appropriate government regulations (e.g., FDA GLPs, OECD guidelines), guidance documents, Company policies, and departmental Standard Operating Procedures (SOPs). This position is responsible for the execution and closure of the assigned global GLP QA audit activities ensuring that the current regulations, policies, and procedures are adhered to at all our company's sites (domestic and international) and at contract facilities worldwide. Assignments are of increased complexity and solves complex problems. Will function as a team or project lead as required promoting open discussion of issues.

Primary Responsibilities

• Facilitates communication and alignment with key stakeholders upstream and downstream.
• Conducts wide range of GLP, regulated Bioanalysis/Bioequivalence/Vaccine Clinical Assay audits in accordance with QA risk-based processes. regulations/guidelines, as well as our Company policies, procedures, and industry standards.
• Serves as a Lead Liaison for all QA activities supporting regulated activities within our Company sites (domestic and international) and contract facilities worldwide.
• Provides expert level knowledge of assigned major project/program areas as related to quality assurance issues and strategies. Responsible for the daily activities for assigned projects/programs, including prioritizing, planning, scheduling, monitoring, and