Director of Quality Assurance & Complaint Management

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ, USA seeks an Associate Director to guide the Manufacturing division's product quality complaint management in compliance with worldwide MDCP regulatory expectations.

You will serve as SME for receipt, handling, trending and adverse event reporting, coordinating with Global Safety, manufacturing sites and external partners. The role requires leadership across cross-functional teams, strong problem-solving, and written technical communication.

Qualifications

• Bachelor's degree with 7+ years of 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 or related fields.
• Strong leadership and ability to manage multiple projects with competing priorities.
• Excellent problem-solving, communication, collaboration, and cross-cultural skills.

Responsibilities

• Provide guidance to ensure MDCP regulatory expectations are met for product quality complaints.
• Serve as subject matter expert for PQC, adverse event quality, and regulatory reporting.
• Contribute to policy/procedure development and QA Manual alignment.
• Support regulatory inspections and liaise between manufacturing sites, safety, and external partners.
• Lead cross-functional teams to improve PQC processes, including use of data, tech, and automation.
• Mentor team members and align activities with department objectives.

Skills

Regulatory CMC

Quality management

Leadership

Cross-functional teamwork

Regulatory liaison

Problem solving

Independent work

Education

Bachelor's degree in Science/Engineering

Master's degree (Science/Engineering)

Ph.D. (Science/Engineering)

Job description

Merck & Co., Inc. in Rahway, NJ, USA seeks an Associate Director to guide the Manufacturing division's product quality complaint management in compliance with worldwide MDCP regulatory expectations.

You will serve as SME for receipt, handling, trending and adverse event reporting, coordinating with Global Safety, manufacturing sites and external partners. The role requires leadership across cross-functional teams, strong problem-solving, and written technical communication.