Senior Specialist Digital and Data Quality
Merck · Durham (old Oxford), NC
QualityFull-time$106k–$167kCompany career page
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Role summary
Senior Specialist responsible for quality oversight of computerized systems and digital infrastructure across manufacturing, packaging, and laboratory operations at a pharmaceutical facility. Will ensure GMP compliance, regulatory adherence, and data integrity while collaborating with cross-functional teams on system lifecycle management and continuous improvement.
What they're looking for
- Bachelor's degree in Science, Information Technology, Engineering, or equivalent discipline
- Minimum 5 years pharmaceutical manufacturing experience in regulated environment
- At least 3 years delivering validated IT solutions or application support in regulated setting
- Extensive knowledge of computerized system validation, compliance principles, and theories
- Strong understanding of FDA 21 CFR Part 11, 210, 211, 820 and ICH regulations
- Hands-on experience with automated systems in pharmaceutical manufacturing or laboratory operations
What you'll be doing
- Assess and remediate legacy systems; evaluate and implement new computerized systems supporting GxP processes
- Provide independent quality approval of validation documentation, policies, procedures, and system-related changes
- Ensure system owners maintain operating procedures and validated status through change control and periodic review
- Support regulatory inspections and audit activities; drive resolution of GxP non-conformance findings
- Mentor junior team members and contribute to training program development on validation and regulatory principles
Privacy & handoff
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