GxP Digital Quality & Validation Specialist

MSD; North Carolina; Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Job summary

MSD seeks a Sr. Specialist in Digital and Data Quality to lead quality oversight of GMP computerized systems and supporting infrastructure across site facilities, utilities, manufacturing, and laboratories.

You will partner with SMEs to ensure data integrity and regulatory compliance throughout the system lifecycle. You will drive improvements, review qualification/validation documentation, and support audits while mentoring junior staff and promoting a culture of continuous improvement in a GMP

Qualifications

• Hands-on experience in automated systems supporting pharmaceutical manufacturing and IT infrastructure.
• Min 5 years in regulated pharmaceutical manufacturing.
• At least 3 years delivering validated IT solutions in a regulated environment.
• Strong understanding of FDA/EU/ICH regulations and 21 CFR Part 11, 210, 211, 820.
• Knowledge of computerized system validation / compliance and quality systems.

Responsibilities

• Assess and remediate legacy systems and evaluate/implement new computerized systems.
• Ensure technologies meet high-level business needs and promote efficiency.
• Interface with IT, quality, operations and engineering to align capabilities with quality policies.
• Provide independent quality approval of SDLC documentation and changes.
• Mentor junior team members and monitor system health and compliance.

Skills

Adaptability

cGMP Regulations

Change Management

Deviation Management

GAMP

Quality Assurance

Regulatory Compliance

Risk Management

Project Management

Education

Bachelor’s degree (Science/IT/Engineering)

Job description

MSD seeks a Sr. Specialist in Digital and Data Quality to lead quality oversight of GMP computerized systems and supporting infrastructure across site facilities, utilities, manufacturing, and laboratories.

You will partner with SMEs to ensure data integrity and regulatory compliance throughout the system lifecycle. You will drive improvements, review qualification/validation documentation, and support audits while mentoring junior staff and promoting a culture of continuous improvement in a GMP