QA Associate Director - Global Complaints & Regulatory Lead

Merck; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking an Associate Director to guide the Manufacturing division's product quality complaint management, ensuring compliance with worldwide MDCP regulatory expectations. The role serves as a subject matter expert for receipt, handling, trending, and health authority reporting of PQCs.

You will collaborate with Global Safety, site operations, and external partners to address investigations, lead cross-functional teams, and drive continuous improvements in processes, including the use of

Qualifications

• Bachelor’s degree in Science or Engineering with 7+ years related experience (or Master’s with 5, or PhD with 3)
• Experience with Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products
• Strong leadership, project management and cross-functional collaboration skills
• Excellent problem-solving, written and verbal communication in a matrix, multi-cultural environment
• Ability to identify and implement continuous improvement using technology and AI where applicable

Responsibilities

• Oversee receipt and handling of product quality complaints, trending and reporting of PQCs and AE quality investigations.
• Provide SME guidance for Quality Manual Chapter 8 and update procedures.
• Support regulatory inspections and inter-divisional linkages for devices and pharmacovigilance.
• Coordinate with Global Safety, Manufacturing sites, and external partners on investigations.
• Lead cross-functional teams to develop processes and databases for PQC management and signaling.

Skills

Regulatory knowledge

Quality management

Leadership

Cross-functional collaboration

Technical writing

Education

Bachelor's degree in Science/Engineering

Master's degree in Science/Engineering

Ph.D. in Science/Engineering

Job description

Merck is seeking an Associate Director to guide the Manufacturing division's product quality complaint management, ensuring compliance with worldwide MDCP regulatory expectations. The role serves as a subject matter expert for receipt, handling, trending, and health authority reporting of PQCs.

You will collaborate with Global Safety, site operations, and external partners to address investigations, lead cross-functional teams, and drive continuous improvements in processes, including the use of