Senior Digital & Data Quality Specialist (GxP)

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

Benefits offered by this job

Hybrid work arrangement

Benefits package including medical, Rx

Job summary

Merck & Co. is seeking a Sr. Specialist Digital and Data Quality to ensure quality of GMP computerized systems across manufacturing, packaging, labeling, and labs. You will collaborate with site operations, IT, automation and engineering to evidence quality oversight throughout the system lifecycle.

The role requires deep GMP quality understanding, regulatory knowledge, and independent judgment to drive continuous improvement and adherence to ALCOA data integrity principles.

Qualifications

• Hands-on experience with automated systems in pharma/manufacturing or labs.
• Experience in delivering validated IT solutions in regulated environments.
• Knowledge of FDA/EU/ICH regulations, including 21 CFR 11, 210, 211, 820.

Responsibilities

• Ensure selected technologies meet business needs while enabling compliance.
• Interface with IT and QA to align capabilities with quality policies.
• Provide independent quality approvals for documentation and changes.

Skills

Quality oversight

Regulatory understanding

GxP awareness

Data integrity

Computerized systems

Problem solving

Communication

Auditing

Education

Bachelor's degree

Job description

Merck & Co. is seeking a Sr. Specialist Digital and Data Quality to ensure quality of GMP computerized systems across manufacturing, packaging, labeling, and labs. You will collaborate with site operations, IT, automation and engineering to evidence quality oversight throughout the system lifecycle.

The role requires deep GMP quality understanding, regulatory knowledge, and independent judgment to drive continuous improvement and adherence to ALCOA data integrity principles.