Lead, Complaints / Adverse Events (CSV)
Johnson & Johnson
10 days ago
Remote friendly (Raritan, NJ)
United States
Medical Affairs
Responsibilities
- Guide and manage the team to build and execute quality into enterprise systems, tools, services, and infrastructure across the full lifecycle (design, develop, implement, maintain, retire).
- Ensure J&J quality standards and global regulatory requirements are met.
- Ensure early Quality involvement in design/development; integrate controls into applications/solutions and leverage automation where feasible.
- Own end-to-end quality process/strategy; provide technical guidance to project teams.
- Plan, allocate, execute, coordinate, and maintain GxP validation activities.
- Support internal audits and Health Authority inspections; approve SDLC validation deliverables and production releases/changes.
- Manage incident management/CAPA and nonconformities; review/approve validation deliverables (Compliance Plans, User Requirements/User Stories, System Tests, UAT, Traceability Matrices, Compliance Reports).
- Stakeholder and people leadership (partner with teams; mentor/manage consultants/providers).
Required Qualifications
- BS or equivalent experience.
- 6+ years in pharma/medical device/biotech with direct Computerized System Validation (CSV) experience.
Preferred Qualifications/Skills
- Experience with large-scale validation programs (LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, Change Control).
- Author/approve validation protocols, non-conformities, Change Requests, SOPs, Validation Plans/Reports.
- Familiarity with JIRA Xray, Qtest, JIRA, Jenkins, Selenium; Agile/SAFe/CI-CD.
- cGMP CSV knowledge (21 CFR Part 11, 210, 211, 820); ISO/EU Annex 11/SOX/ITIL/GAMP 5 (preferred).
Benefits (as stated)
- Vacation: 120 hours/year; Sick time: 40 hours/year (state variations noted); Holiday pay (13 days); Work/Personal/Family time (up to 40 hours); Parental leave (480 hours); Bereavement (240/40 extended); Caregiver leave; Volunteer and Military Spouse Time-Off (hours as stated).
- Guide and manage the team to build and execute quality into enterprise systems, tools, services, and infrastructure across the full lifecycle (design, develop, implement, maintain, retire).
- Ensure J&J quality standards and global regulatory requirements are met.
- Ensure early Quality involvement in design/development; integrate controls into applications/solutions and leverage automation where feasible.
- Own end-to-end quality process/strategy; provide technical guidance to project teams.
- Plan, allocate, execute, coordinate, and maintain GxP validation activities.
- Support internal audits and Health Authority inspections; approve SDLC validation deliverables and production releases/changes.
- Manage incident management/CAPA and nonconformities; review/approve validation deliverables (Compliance Plans, User Requirements/User Stories, System Tests, UAT, Traceability Matrices, Compliance Reports).
- Stakeholder and people leadership (partner with teams; mentor/manage consultants/providers).
Required Qualifications
- BS or equivalent experience.
- 6+ years in pharma/medical device/biotech with direct Computerized System Validation (CSV) experience.
Preferred Qualifications/Skills
- Experience with large-scale validation programs (LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, Change Control).
- Author/approve validation protocols, non-conformities, Change Requests, SOPs, Validation Plans/Reports.
- Familiarity with JIRA Xray, Qtest, JIRA, Jenkins, Selenium; Agile/SAFe/CI-CD.
- cGMP CSV knowledge (21 CFR Part 11, 210, 211, 820); ISO/EU Annex 11/SOX/ITIL/GAMP 5 (preferred).
Benefits (as stated)
- Vacation: 120 hours/year; Sick time: 40 hours/year (state variations noted); Holiday pay (13 days); Work/Personal/Family time (up to 40 hours); Parental leave (480 hours); Bereavement (240/40 extended); Caregiver leave; Volunteer and Military Spouse Time-Off (hours as stated).