Hybrid Senior Digital and Data Quality Lead

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

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Merck & Co., Inc., Rahway, NJ, USA is seeking a Senior Specialist in Digital & Data Quality to oversee computerized systems within pharmaceutical manufacturing. The role focuses on ensuring QMS alignment, validation, and regulatory readiness across sites.

The ideal candidate has deep GxP knowledge, extensive experience with validated IT solutions, and the ability to collaborate across IT, quality, operations, and engineering.

Qualifications

• Bachelor's degree in Science, Information Technology, Engineering or equivalent.
• Min 5 years in regulated pharmaceutical manufacturing.
• At least 3 years delivering validated IT solutions in a regulated environment.
• Strong knowledge of FDA/EU/ICH regs (21 CFR 11, 210, 211, 820).
• Experience implementing quality systems in pharma, lab, or biotech.
• Limited supervision in day-to-day activities.

Responsibilities

• Assess and remediate legacy systems and evaluate new computerized systems.
• Ensure technologies meet high-level business needs and drive efficiency.
• Provide independent quality approval of validation docs (policies, procedures, plans, reports).
• Maintain validated status through lifecycle activities (change control, periodic review, investigations).
• Support regulatory inspections and audit activities as needed.
• Promote GxP awareness and continuous improvement.
• Mentor junior team members.

Skills

Quality systems

GxP compliance

Documentation QA

Regulatory knowledge

Project management

Cross-functional collaboration

Education

Bachelor's degree in Science/IT/Engineering

Job description

Merck & Co., Inc., Rahway, NJ, USA is seeking a Senior Specialist in Digital & Data Quality to oversee computerized systems within pharmaceutical manufacturing. The role focuses on ensuring QMS alignment, validation, and regulatory readiness across sites.

The ideal candidate has deep GxP knowledge, extensive experience with validated IT solutions, and the ability to collaborate across IT, quality, operations, and engineering.