Senior GxP Digital & Data Quality Specialist

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck is seeking a Sr. Specialist in Digital and Data Quality to oversee quality aspects of GMP computerized systems across manufacturing and labs.

You will partner with IT, automation and operations to ensure data integrity, validation, and regulatory compliance throughout the system lifecycle. The role requires extensive experience with validated IT solutions in a regulated pharmaceutical environment, strong collaboration skills, and the ability to drive continuous improvement across site

Qualifications

• Bachelor's degree in Science, IT, Engineering or equivalent.
• Hands-on experience with automated systems in pharma manufacturing or GMP environments.
• Strong knowledge of FDA/EU/ICH regulations and 21 CFR Part 11/210/211/820.

Responsibilities

• Own and oversee qualification/validation documentation to ensure compliance.
• Collaborate with IT, engineering, quality, and operations to maintain system lifecycle.
• Support regulatory inspections and address findings related to IT applications and equipment.
• Promote data integrity and continuous improvement across sites.

Skills

Adaptability

cGMP Regulations

Change Management

Deviation Management

GAMP

Quality Assurance

Regulatory Compliance

Risk Management

Project Management

Education

Bachelor's degree in Science/IT/Engineering

Job description

Merck is seeking a Sr. Specialist in Digital and Data Quality to oversee quality aspects of GMP computerized systems across manufacturing and labs.

You will partner with IT, automation and operations to ensure data integrity, validation, and regulatory compliance throughout the system lifecycle. The role requires extensive experience with validated IT solutions in a regulated pharmaceutical environment, strong collaboration skills, and the ability to drive continuous improvement across site