Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality
Johnson & Johnson
9 days ago
Remote friendly (New Brunswick, NJ)
United States
Corporate Functions
Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality
You will be responsible for:
- Define and manage the Acquisitions, Divestitures and Remediation operating model.
- Execute TQ assessments for IT systems conveyed from acquisitions/divestitures (infrastructure, applications, healthcare technology systems).
- Oversee qualification/validation reviews for conveyed IT GxP systems (Manufacturing, Lab, R&D, Infrastructure, IT tools, websites, mobile apps, SAMD, Supply Chain).
- Provide strategic/operational support to project teams; ensure early TQ& C involvement for preventive/automated controls.
- Manage end-to-end quality processes; implement/manage TQ metrics and reporting for A&D assessments, integration/separation, and remediation.
- Lead inspection/audit readiness; participate in audits and approve NC action plans and closure.
- Perform validation deliverable review/approval (e.g., compliance plans, requirements/user stories, tests, traceability matrices, compliance reports).
- Lead risk management and provide compliance guidance (NC/CAPA, due diligence, mitigations/workarounds).
- Manage scope/schedule, resources, intake/budgeting as Power User; track outcomes; identify automation opportunities (AI/RPA).
Qualifications/Requirements:
- Bachelor’s degree (Computer Science/IS/Business or related); advanced degree preferred.
- 8–10+ years in pharma/med device/biotech with direct CSV experience, especially acquisitions/divestitures.
- Strong matrix leadership, stakeholder communication, analytical/problem-solving, and executive presence.
- Working knowledge of cGMP/CSV including 21 CFR Part 11, 210, 211, 820, Annex 11; PMO/SDLC/GAMP 5/ITIL; global GxP regs; tech risk assessments.
Preferred skills:
- Compliance Management, Controls Compliance, Digital Assurance/Governance, Fact-Based Decision Making, Quality Management Systems (QMS), Quality Validation, Regulatory Compliance, Stakeholder Engagement, SOP, Technical Credibility.
Benefits (time off per policy): Vacation (120 hrs/yr), Sick time (40 hrs/yr; CO 48; WA 56), Holiday pay (13 days/yr), Work/Personal/Family Time (up to 40 hrs/yr), Parental Leave (480 hrs/yr).
You will be responsible for:
- Define and manage the Acquisitions, Divestitures and Remediation operating model.
- Execute TQ assessments for IT systems conveyed from acquisitions/divestitures (infrastructure, applications, healthcare technology systems).
- Oversee qualification/validation reviews for conveyed IT GxP systems (Manufacturing, Lab, R&D, Infrastructure, IT tools, websites, mobile apps, SAMD, Supply Chain).
- Provide strategic/operational support to project teams; ensure early TQ& C involvement for preventive/automated controls.
- Manage end-to-end quality processes; implement/manage TQ metrics and reporting for A&D assessments, integration/separation, and remediation.
- Lead inspection/audit readiness; participate in audits and approve NC action plans and closure.
- Perform validation deliverable review/approval (e.g., compliance plans, requirements/user stories, tests, traceability matrices, compliance reports).
- Lead risk management and provide compliance guidance (NC/CAPA, due diligence, mitigations/workarounds).
- Manage scope/schedule, resources, intake/budgeting as Power User; track outcomes; identify automation opportunities (AI/RPA).
Qualifications/Requirements:
- Bachelor’s degree (Computer Science/IS/Business or related); advanced degree preferred.
- 8–10+ years in pharma/med device/biotech with direct CSV experience, especially acquisitions/divestitures.
- Strong matrix leadership, stakeholder communication, analytical/problem-solving, and executive presence.
- Working knowledge of cGMP/CSV including 21 CFR Part 11, 210, 211, 820, Annex 11; PMO/SDLC/GAMP 5/ITIL; global GxP regs; tech risk assessments.
Preferred skills:
- Compliance Management, Controls Compliance, Digital Assurance/Governance, Fact-Based Decision Making, Quality Management Systems (QMS), Quality Validation, Regulatory Compliance, Stakeholder Engagement, SOP, Technical Credibility.
Benefits (time off per policy): Vacation (120 hrs/yr), Sick time (40 hrs/yr; CO 48; WA 56), Holiday pay (13 days/yr), Work/Personal/Family Time (up to 40 hrs/yr), Parental Leave (480 hrs/yr).