Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality
Johnson & Johnson
13 hours ago
Remote friendly (Raritan, NJ)
United States
Corporate Functions
Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality
Purpose: Technology Quality and Compliance (TQ&C) manages Quality and Compliance for IT systems (applications, infrastructure, and digital health solutions). Serves as SME for validation/qualification per J&J SDLC and CSV Framework; ensures enterprise compliance with global regulations; helps close audit/inspection gaps; drives improvements via data-driven independent monitoring.
You will be responsible for:
- Defining and managing the Acquisitions/Divestitures/Remediation operating model
- Executing TQ assessment strategy/framework for IT systems conveyed from acquisitions
- Assessing qualification/validation of conveyed IT GxP systems (Manufacturing, Lab, R&D, Infrastructure, IT tools, websites, mobile apps, SAMD, supply chain)
- Executing divestiture strategy for IT systems in brand/company separations
- Providing strategic direction and operational support to project teams; ensuring early TQ&C involvement to build automated/preventive controls
- Managing end-to-end quality process; implementing/maintaining A&D metrics and reporting
- Translating A&D strategy into operational plans and ensuring global consistency; supporting new/emerging technology qualification/validation strategies
- Ensuring inspection/audit readiness; participating in audits and approving NC action plans/closure
- Supporting incident management/CAPA and NC; reviewing/approving validation deliverables (plans, requirements/user stories, tests, traceability matrices, compliance reports, production release)
- Proactively monitoring compliance with SOPs and best practices; identifying automation opportunities (AI/RPA)
- Stakeholder management, risk management, and project management for A&D initiatives (including due diligence and intake/budget/resource management)
Qualifications/Requirements:
- Bachelor’s degree (Computer Science/IS/Business Adm. or related); advanced degree preferred
- 8–10+ years in pharma/med device/biotech with direct CSV experience, particularly acquisitions/divestitures
- Strong matrix/global collaboration and stakeholder communication/influencing
- People leadership, decision-making, executive presence, analytical/problem-solving skills
- Working knowledge of cGMP/CSV including 21 CFR Part 11/210/211/820 and Annex 11; PMO, SDLC, GAMP 5, ITIL; security role design/segregation of duties
- Familiarity with cybersecurity/privacy principles; understanding of global/regional GxP regs; experience with technology risk assessments
Benefits (time off): Vacation 120 hrs/yr; Sick time 40 hrs/yr (CO 48; WA 56); Holiday/Floating 13 days/yr; Work/Personal/Family up to 40 hrs/yr; Parental leave 480 hrs; Bereavement 240 hrs (immediate) and 40 hrs extended/yr; Caregiver leave 80 hrs; Volunteer 32 hrs/yr; Military spouse time-off 80 hrs/yr.
Purpose: Technology Quality and Compliance (TQ&C) manages Quality and Compliance for IT systems (applications, infrastructure, and digital health solutions). Serves as SME for validation/qualification per J&J SDLC and CSV Framework; ensures enterprise compliance with global regulations; helps close audit/inspection gaps; drives improvements via data-driven independent monitoring.
You will be responsible for:
- Defining and managing the Acquisitions/Divestitures/Remediation operating model
- Executing TQ assessment strategy/framework for IT systems conveyed from acquisitions
- Assessing qualification/validation of conveyed IT GxP systems (Manufacturing, Lab, R&D, Infrastructure, IT tools, websites, mobile apps, SAMD, supply chain)
- Executing divestiture strategy for IT systems in brand/company separations
- Providing strategic direction and operational support to project teams; ensuring early TQ&C involvement to build automated/preventive controls
- Managing end-to-end quality process; implementing/maintaining A&D metrics and reporting
- Translating A&D strategy into operational plans and ensuring global consistency; supporting new/emerging technology qualification/validation strategies
- Ensuring inspection/audit readiness; participating in audits and approving NC action plans/closure
- Supporting incident management/CAPA and NC; reviewing/approving validation deliverables (plans, requirements/user stories, tests, traceability matrices, compliance reports, production release)
- Proactively monitoring compliance with SOPs and best practices; identifying automation opportunities (AI/RPA)
- Stakeholder management, risk management, and project management for A&D initiatives (including due diligence and intake/budget/resource management)
Qualifications/Requirements:
- Bachelor’s degree (Computer Science/IS/Business Adm. or related); advanced degree preferred
- 8–10+ years in pharma/med device/biotech with direct CSV experience, particularly acquisitions/divestitures
- Strong matrix/global collaboration and stakeholder communication/influencing
- People leadership, decision-making, executive presence, analytical/problem-solving skills
- Working knowledge of cGMP/CSV including 21 CFR Part 11/210/211/820 and Annex 11; PMO, SDLC, GAMP 5, ITIL; security role design/segregation of duties
- Familiarity with cybersecurity/privacy principles; understanding of global/regional GxP regs; experience with technology risk assessments
Benefits (time off): Vacation 120 hrs/yr; Sick time 40 hrs/yr (CO 48; WA 56); Holiday/Floating 13 days/yr; Work/Personal/Family up to 40 hrs/yr; Parental leave 480 hrs; Bereavement 240 hrs (immediate) and 40 hrs extended/yr; Caregiver leave 80 hrs; Volunteer 32 hrs/yr; Military spouse time-off 80 hrs/yr.