GxP Digital & Data Quality Lead - Hybrid

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

Job summary

MSD is seeking a Senior Specialist in Digital and Data Quality to oversee GMP computerized systems across site facilities, manufacturing, packaging, labeling and laboratories, ensuring compliance with policies and regulations.

You will collaborate with IT, operations, quality operations and engineering to deliver validated systems, support audits, and drive continuous improvement in data integrity and ALCOA principles.

Qualifications

• Bachelor's degree in science, IT, engineering or equivalent.
• Hands-on experience with automated systems supporting pharmaceutical manufacturing or lab operations.
• 5+ years in regulated pharmaceutical manufacturing.
• 3+ years delivering validated IT solutions or application support in a regulated environment.
• Strong knowledge of FDA/EU/ICH regulations (21 CFR 11, 210, 211, 820).

Responsibilities

• Assess and remediate legacy systems and evaluate new computerized systems to enable GxP processes.
• Provide independent quality approval of qualification/validation docs and system changes.
• Ensure system owners have procedures in place and maintain validated status; manage changes, investigations, and data reviews.
• Support regulatory inspections and audit activities; address findings related to IT applications and lab systems.
• Mentor junior team members and promote continuous improvement in validation and data integrity.

Skills

GxP

Quality Assurance

Regulatory Compliance

Computer System Validation

IT Infrastructure

Change Control

Education

Bachelor's degree

Job description

MSD is seeking a Senior Specialist in Digital and Data Quality to oversee GMP computerized systems across site facilities, manufacturing, packaging, labeling and laboratories, ensuring compliance with policies and regulations.

You will collaborate with IT, operations, quality operations and engineering to deliver validated systems, support audits, and drive continuous improvement in data integrity and ALCOA principles.