Senior Specialist, Digital & Data Quality
Merck
5 hours ago
Remote friendly (Wilmington, DE)
United States
IT
Responsibilities:
- Ensure quality oversight of GMP computerized systems and supporting infrastructure (facilities, utilities, manufacturing, packaging/labeling, and labs) to meet company policies and regulatory expectations.
- Collaborate with stakeholders/SMEs to assess and remediate legacy systems and evaluate/implement new GxP computerized systems.
- Provide independent quality approval of qualification/validation and computerized system documentation (policies, procedures, acceptance criteria, plans/protocols, specifications, reports, and change-related documentation).
- Verify system owners maintain validated status via procedures/plans (e.g., incident/problem management, change control, periodic review, investigations, backup/restore, SOPs, disaster recovery, business continuity).
- Review evidence of compliance effectiveness; support audits/inspections; resolve regulatory non-conformance; communicate system health/compliance metrics.
- Promote GxP awareness/continuous improvement; represent Digital & Data Quality as needed; support training; review/approve SDLC documentation; mentor junior staff.
Qualifications:
- Bachelor’s degree (preferred in Science, IT, Engineering, or equivalent).
- Hands-on knowledge of automated systems for pharma manufacturing, IT infrastructure, and/or lab operations.
- 5+ years in regulated pharma manufacturing; 3+ years delivering validated IT solutions or application support in a regulated environment.
- Strong knowledge of pharmaceutical regulations (incl. 21 CFR Part 11, 210, 211, 820) and CSV/computerized system compliance; familiarity with GMP quality systems.
Preferred skills: Six Sigma/PMP (or similar); quality/compliance in GMP; business engagement with technical/non-technical collaboration; regulatory inspection leadership; communication, analytical problem-solving, project management.
Benefits (explicitly stated): medical/dental/vision, 401(k), paid holidays/vacation, and sick/compassionate days; bonus/LTI if applicable.
Application: Apply via https://jobs.merck.com/us/en (deadline stated on posting). Requisition ID: R376922.
- Ensure quality oversight of GMP computerized systems and supporting infrastructure (facilities, utilities, manufacturing, packaging/labeling, and labs) to meet company policies and regulatory expectations.
- Collaborate with stakeholders/SMEs to assess and remediate legacy systems and evaluate/implement new GxP computerized systems.
- Provide independent quality approval of qualification/validation and computerized system documentation (policies, procedures, acceptance criteria, plans/protocols, specifications, reports, and change-related documentation).
- Verify system owners maintain validated status via procedures/plans (e.g., incident/problem management, change control, periodic review, investigations, backup/restore, SOPs, disaster recovery, business continuity).
- Review evidence of compliance effectiveness; support audits/inspections; resolve regulatory non-conformance; communicate system health/compliance metrics.
- Promote GxP awareness/continuous improvement; represent Digital & Data Quality as needed; support training; review/approve SDLC documentation; mentor junior staff.
Qualifications:
- Bachelor’s degree (preferred in Science, IT, Engineering, or equivalent).
- Hands-on knowledge of automated systems for pharma manufacturing, IT infrastructure, and/or lab operations.
- 5+ years in regulated pharma manufacturing; 3+ years delivering validated IT solutions or application support in a regulated environment.
- Strong knowledge of pharmaceutical regulations (incl. 21 CFR Part 11, 210, 211, 820) and CSV/computerized system compliance; familiarity with GMP quality systems.
Preferred skills: Six Sigma/PMP (or similar); quality/compliance in GMP; business engagement with technical/non-technical collaboration; regulatory inspection leadership; communication, analytical problem-solving, project management.
Benefits (explicitly stated): medical/dental/vision, 401(k), paid holidays/vacation, and sick/compassionate days; bonus/LTI if applicable.
Application: Apply via https://jobs.merck.com/us/en (deadline stated on posting). Requisition ID: R376922.