Senior Digital & Data Quality Specialist (GxP)

Merck & Co.; Durham (NC); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck & Co. in Durham, NC is seeking a Sr. Specialist Digital and Data Quality to oversee quality aspects of GMP computerized systems across manufacturing, labeling, labs, and utilities, ensuring compliance with company policies and regulatory expectations.

The role collaborates with site operations, IT, automation, and engineering to provide quality oversight, manage SDLC documentation, and drive continuous improvement while mentoring junior team members.

Qualifications

• Bachelor's degree in science, IT, engineering or equivalent.
• Hands-on experience with automated pharmaceutical systems.
• Knowledge of FDA/EU/ICH regulations and 21 CFR parts.
• Experience delivering validated IT solutions in regulated environments.
• Strong ability to work with cross-functional teams.

Responsibilities

• Assess and remediate legacy systems to enable GxP processes.
• Provide independent quality approval of validation documents.
• Ensure system ownership maintains validated status.
• Support regulatory inspections and respond to findings.
• Mentor junior team members and drive continuous improvement.

Skills

GxP compliance

Regulatory knowledge

Quality systems understanding

Cross-functional collaboration

Project management

Education

Bachelor's degree in Science/IT/Engineering

Tools

Validation tools

Quality Management Systems

Job description

Merck & Co. in Durham, NC is seeking a Sr. Specialist Digital and Data Quality to oversee quality aspects of GMP computerized systems across manufacturing, labeling, labs, and utilities, ensuring compliance with company policies and regulatory expectations.

The role collaborates with site operations, IT, automation, and engineering to provide quality oversight, manage SDLC documentation, and drive continuous improvement while mentoring junior team members.