QA Strategy Director - Complaints & Compliance

Merck & Co.; Upper Gwynedd Township (Montgomery County); Ibrido; USD 142.000 - 224.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Long-term incentive

Health benefits

Descrizione del lavoro

Merck & Co. seeks an Associate Director to guide the Manufacturing division’s product quality complaint management, ensuring compliance with global MDCP regulatory expectations.

This role serves as SME for complaint handling, trending, and regulatory reporting across cross-functional teams. The candidate will collaborate with Global Safety, site teams, and external partners to ensure timely investigations and health authority reporting, while aligning with QMS and regulatory trends.

Competenze

• Bachelor's or higher in science/engineering with related experience.
• Experience in regulatory CMC, quality, development, manufacturing, testing or licensure of pharmaceutical products.
• Strong leadership and project management skills in a matrix environment.

Mansioni

• Oversee complaint management processes and regulatory reporting for PQCs and AE quality investigations.
• Provide SME guidance on Quality Manual Chapter 8 and regulatory alignment.
• Support regulatory inspections and liaise with device/tech and safety groups.

Conoscenze

Regulatory CMC

Quality Assurance

Leadership

Cross-Functional

Problem Solving

Documentation

Formazione

Bachelor's in Science or Engineering

Master's in Science or Engineering

PhD in Science or Engineering

Strumenti

Regulatory Tools

Descrizione del lavoro

Merck & Co. seeks an Associate Director to guide the Manufacturing division’s product quality complaint management, ensuring compliance with global MDCP regulatory expectations.

This role serves as SME for complaint handling, trending, and regulatory reporting across cross-functional teams. The candidate will collaborate with Global Safety, site teams, and external partners to ensure timely investigations and health authority reporting, while aligning with QMS and regulatory trends.