Associate Director, Quality Assurance - Complaints Lead

Merck; New Jersey; On-site; USD 170,000 - 210,000; Full time

Job summary

Merck in New Jersey is seeking an Associate Director to guide the manufacturing quality complaint management for MDCP regulatory expectations worldwide. You will serve as SME for complaint handling, trending, and health authority reporting with Global Safety and site teams.

You will lead cross-functional initiatives, align with Quality Manual Chapter 8, support regulatory inspections, and mentor team members while driving process improvements through technology and data analytics.

Qualifications

• Bachelor's degree in Science or Engineering with 7+ years related experience, or Master's with 5+ years, or PhD with 3 years.
• Experience in Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products.
• Strong leadership and ability to manage multiple projects with competing priorities.
• Excellent problem-solving skills based on data, science, and regulatory understanding.

Responsibilities

• Oversee receipt and handling of product quality complaints and adverse event reporting.
• Coordinate investigations with Global Safety, manufacturing sites, and external partners.
• Provide SME input to Quality Manual Chapter 8 and keep documentation current.
• Support regulatory inspections related to product quality complaints.
• Lead cross-functional teams to improve complaint management processes.

Skills

Regulatory knowledge

Quality management

Cross-functional leadership

Problem solving

Communication skills

Education

Bachelor in Science or Engineering

Master's in Science or Engineering

PhD in Science or Engineering

Job description

Merck in New Jersey is seeking an Associate Director to guide the manufacturing quality complaint management for MDCP regulatory expectations worldwide. You will serve as SME for complaint handling, trending, and health authority reporting with Global Safety and site teams.

You will lead cross-functional initiatives, align with Quality Manual Chapter 8, support regulatory inspections, and mentor team members while driving process improvements through technology and data analytics.