Senior Digital & Data Quality Lead (GxP)

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

Job summary

Merck in the United States seeks a Sr. Specialist Digital and Data Quality to oversee GMP computerized systems quality across manufacturing, labs, and infrastructure.

The role collaborates with site operations, IT, automation and engineering to ensure data integrity and regulatory compliance throughout the lifecycle. The ideal candidate has 5+ years in regulated pharma, deep knowledge of 21 CFR 11/210/211/820, and proven IT validation delivery in GMP environments.

Qualifications

• Bachelor's degree and hands-on experience in automated systems in pharma.
• Strong knowledge of FDA/EU/ICH regulations and 21 CFR 11, 210, 211, 820.
• Experience delivering validated IT solutions in regulated environments.

Responsibilities

• Assess and remediate legacy systems and evaluate new computerized systems.
• Ensure compliance of QC/QA and IT with quality policies and standards.
• Provide independent quality approvals of validation documents and change controls.
• Support regulatory inspections and remediation of findings.

Skills

Adaptability

cGMP Regulations

Change Management

Deviation Management

GAMP

Manufacturing Quality Control

Pharmaceutical Quality Assurance

Product Disposition

Quality Auditing

Quality Management Standards

Regulatory Compliance

Risk Management

Self Motivation

Strategic Planning

Education

Bachelor's degree in Science/IT or equivalent

Job description

Merck in the United States seeks a Sr. Specialist Digital and Data Quality to oversee GMP computerized systems quality across manufacturing, labs, and infrastructure.

The role collaborates with site operations, IT, automation and engineering to ensure data integrity and regulatory compliance throughout the lifecycle. The ideal candidate has 5+ years in regulated pharma, deep knowledge of 21 CFR 11/210/211/820, and proven IT validation delivery in GMP environments.