Lead, Complaints / Adverse Events (CSV)
Johnson & Johnson
9 days ago
Remote friendly (Horsham, PA)
United States
Medical Affairs
Role Responsibilities
- Lead and manage end-to-end quality into enterprise-wide systems, tools, services, and infrastructure across the lifecycle (design, develop, implement, maintain, retire).
- Ensure J&J quality standards and global regulatory requirements are met.
- Own quality approach for supported systems and deliver end-to-end support model.
- Plan, allocate resources, and execute/maintain validation activities for GxP systems/applications.
- Provide guidance to project teams; ensure early quality involvement in design/development and automated/preventive controls.
- Review/approve validation documentation (e.g., Compliance Plans, UR/US, System Tests, UAT, Traceability Matrices, Compliance Reports) including production releases.
- Support audits and Health Authority inspections; approve audit NC action plans and closure.
- Manage consultants/service providers supporting EQ; mentor team and support growth.
Qualifications
- BS or equivalent experience; 6+ years in pharma/medical device/biotech with direct Computerized System Validation experience.
- Experience authoring/approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans/Reports (required).
Preferred Skills/Knowledge
- QMS, audit management, risk-based approaches; testing tools (Qtest, JIRA Xray); knowledge of cGMP/CSV (21 CFR Part 11, 210, 211, 820 required). Agile/SAFe/CI/CD and tools like JIRA, Jenkins, Selenium preferred.
- Experience with LIMS, CAPA, MES, PLM, SAP, LMS, complaints handling, change control preferred.
Benefits (time off)
- Vacation 120 hrs/yr; Sick 40 hrs/yr (state-based variations); Holiday pay 13 days/yr; Work/Personal/Family up to 40 hrs/yr; Parental leave 480 hrs; Bereavement 240 hrs (immediate) / 40 hrs extended; Caregiver 80 hrs; Volunteer 32 hrs; Military Spouse 80 hrs.
- Lead and manage end-to-end quality into enterprise-wide systems, tools, services, and infrastructure across the lifecycle (design, develop, implement, maintain, retire).
- Ensure J&J quality standards and global regulatory requirements are met.
- Own quality approach for supported systems and deliver end-to-end support model.
- Plan, allocate resources, and execute/maintain validation activities for GxP systems/applications.
- Provide guidance to project teams; ensure early quality involvement in design/development and automated/preventive controls.
- Review/approve validation documentation (e.g., Compliance Plans, UR/US, System Tests, UAT, Traceability Matrices, Compliance Reports) including production releases.
- Support audits and Health Authority inspections; approve audit NC action plans and closure.
- Manage consultants/service providers supporting EQ; mentor team and support growth.
Qualifications
- BS or equivalent experience; 6+ years in pharma/medical device/biotech with direct Computerized System Validation experience.
- Experience authoring/approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans/Reports (required).
Preferred Skills/Knowledge
- QMS, audit management, risk-based approaches; testing tools (Qtest, JIRA Xray); knowledge of cGMP/CSV (21 CFR Part 11, 210, 211, 820 required). Agile/SAFe/CI/CD and tools like JIRA, Jenkins, Selenium preferred.
- Experience with LIMS, CAPA, MES, PLM, SAP, LMS, complaints handling, change control preferred.
Benefits (time off)
- Vacation 120 hrs/yr; Sick 40 hrs/yr (state-based variations); Holiday pay 13 days/yr; Work/Personal/Family up to 40 hrs/yr; Parental leave 480 hrs; Bereavement 240 hrs (immediate) / 40 hrs extended; Caregiver 80 hrs; Volunteer 32 hrs; Military Spouse 80 hrs.