Associate Director, Quality Enablement & Solutions

Johnson & Johnson Innovative Medicine

Titusville (NJ)

On-site

USD 137,000 - 236,000

Full time

16 hours ago

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Benefits offered by this job

Vacation hours

Sick leave

Holiday pay

Parental leave

Bereavement leave

Volunteer leave

Job summary

Johnson & Johnson is seeking an Associate Director, Quality Business Enablement to lead a portfolio of quality solutions within RDQ, coordinating with process owners and senior leaders to drive compliant, value-realizing initiatives. The role focuses on inspection readiness, AI-enabled quality innovation, and scalable digital capabilities across the enterprise.

You will partner with audit, quality systems, and data analytics teams to translate business needs into validated, compliant solutions

Qualifications

10+ years in pharmaceutical, biotechnology, or other regulated industries.
5+ years leading strategic initiatives, including execution, process improvement, and digital enablement.
Inspection and audit intelligence experience.
Proven track record influencing senior leadership and stakeholders through VP level and above.
GxP/GCP, GAMP 5, CSA/CSV, data integrity, audit trail, and 21 CFR Part 11 expertise.
Experience gathering business requirements from process owners and leading delivery of validated or compliance-sensitive solutions.
Experience in agile delivery, product or program governance, UAT oversight, adoption planning, and value realization.
Experience directing vendor or offshore delivery teams preferred.

Responsibilities

Business Partnership & Solution Strategy: understand audit, inspection management, and quality processes; align priorities into a portfolio.
Portfolio Leadership & Delivery Governance: provide program leadership and governance for quality initiatives.
Strategy & Prioritization Influence: evaluate opportunities and align competing requests with clear criteria.
Business Requirements & Value Realization: define outcomes and adoption expectations, translate to scalable solutions.
Inspection Intelligence & Quality Innovation: champion AI-enabled capabilities to strengthen readiness and decision-making.
Compliance, Validation & Risk Management: ensure solutions meet GxP/GCP, data integrity, and validation standards.
Enterprise Partnership & Technology Enablement: liaison to Enterprise AI and JJ Technology for governance.
Change Leadership & Capability Building: drive adoption and sustainable capabilities across the organization.
Vendor & Resource Oversight: manage internal/external resources and ensure quality and compliance.