Senior Digital & Data Quality Specialist (Hybrid)

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

Benefits offered by this job

Medical benefits

Dental & Vision

401(k)

Hybrid work

Paid holidays & vacation

Job summary

Merck is seeking a Sr. Specialist DDQ to provide independent quality oversight across the computerized system lifecycle within our US manufacturing environment. You will work with site operations, IT, automation and engineering to ensure compliance with quality policies and regulatory requirements.

The role focuses on validating IT solutions, maintaining GxP standards, and supporting regulatory inspections. A strong background in pharmaceutical quality systems and change control is required.

Qualifications

• Bachelor's degree in science, IT, engineering or equivalent.
• 5+ years in regulated pharmaceutical manufacturing.
• 3+ years delivering validated IT solutions in a regulated environment.

Responsibilities

• Ensure quality-related activities for computerized systems per Quality Manual.
• Collaborate with site operations, IT, automation and engineering for quality oversight.
• Approve key qualification/validation documents to ensure compliance.

Skills

Quality oversight

GxP compliance

Regulatory knowledge

Quality systems

Documentation

Education

Bachelor's degree in science/IT/engineering

Job description

Merck is seeking a Sr. Specialist DDQ to provide independent quality oversight across the computerized system lifecycle within our US manufacturing environment. You will work with site operations, IT, automation and engineering to ensure compliance with quality policies and regulatory requirements.

The role focuses on validating IT solutions, maintaining GxP standards, and supporting regulatory inspections. A strong background in pharmaceutical quality systems and change control is required.