GxP Digital & Data Quality Leader

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

Benefits offered by this job

Medical, dental, vision care

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

Merck & Co., Inc. seeks a Sr. Specialist Digital and Data Quality to oversee GMP computerized systems quality, ensuring compliance with regulatory expectations and company policies.

You will partner with site operations, IT, automation and engineering to drive system lifecycle quality and continuous improvement. The role requires independent work, strong knowledge of GxP, and experience in regulated pharmaceutical manufacturing, audits, and validation documentation.

Qualifications

• Bachelor's degree or equivalent in science, IT, engineering or related field.
• Hands-on experience with automated systems in regulated pharma environments.
• Strong knowledge of FDA/EU/ICH regulations and 21 CFR Part 11.
• Experience delivering validated IT solutions in GMP settings.
• Ability to lead cross-functional teams and manage projects.

Responsibilities

• Provide independent quality approval of SDLC docs and validation deliverables.
• Support regulatory inspections and respond to findings related to IT applications.
• Ensure computerized systems remain validated and compliant across lifecycle.
• Mentor junior team members and drive continuous improvement initiatives.
• Collaborate with site operations, IT, automation and engineering stakeholders.

Skills

GxP knowledge

Quality systems

Regulatory compliance

Project management

Effective communication

Education

Bachelor's degree in Science, IT, Engineering or equivalent

Job description

Merck & Co., Inc. seeks a Sr. Specialist Digital and Data Quality to oversee GMP computerized systems quality, ensuring compliance with regulatory expectations and company policies.

You will partner with site operations, IT, automation and engineering to drive system lifecycle quality and continuous improvement. The role requires independent work, strong knowledge of GxP, and experience in regulated pharmaceutical manufacturing, audits, and validation documentation.