Director, Quality Enablement & Strategy

Johnson & Johnson Co.; Titusville (NJ); On-site; USD 137,000 - 236,000; Full time

Benefits offered by this job

Vacation time

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Caregiver Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking an Associate Director, Quality Business Enablement to join the RDQ quality function. Located at multiple sites including Raritan, NJ and Titusville, NJ, the role partners with process owners to shape a portfolio of quality solutions that improve compliance and operational efficiency.

The role requires 10+ years in regulated industries, strong leadership, and deep GxP knowledge, with a track record in agile delivery, UAT, and adoption planning.

Qualifications

• Bachelor’s degree in a relevant field, MS/PhD preferred.
• 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 through VP level and above.
• Deep expertise in GxP/GCP requirements, GAMP 5, CSA/CSV, data integrity, audit trail, and 21 CFR Part 11 expectations.
• Experience in agile delivery, product or program governance, UAT oversight, adoption planning, and value realization.
• Experience directing vendor or offshore delivery teams preferred.
• Strong collaboration, alignment, change leadership, and influencing skills across a matrixed organization.
• High accuracy, attention to detail, and excellent interpersonal, oral and written communication skills.

Responsibilities

• Partner with process owners and leaders to understand current audit, inspection management, and quality systems processes and align them into a portfolio of solutions.
• Provide program leadership and governance for quality solution initiatives throughout the lifecycle.
• Facilitate evaluation of opportunities and influence prioritization and investment decisions.
• Define business outcomes, success measures, and adoption expectations for scalable solutions.
• Champion inspection intelligence, audit analytics, automation, and AI-enabled capabilities across RDQ and future cross-GxP use cases.
• Ensure solutions are developed and maintained under GxP/GCP and compliance frameworks with proper validation documentation.
• Liaise with Enterprise AI, JJIM Quality Data & Analytics, and Johnson & Johnson Technology for enterprise alignment.
• Drive stakeholder engagement, training, and adoption activities to ensure long-term sustainability of quality solutions.
• Provide direction to internal/external resources and ensure outputs meet quality and compliance expectations.
• Communicate portfolio priorities, progress, risks, decisions needed, and realized value to senior leadership on cadence.
• Interpret ambiguous problems, propose solutions, and implement improvements.
• Manage complex initiatives with independence to meet timelines and outcomes.
• Stay aware of regulatory developments for AI-enabled decision-making in GxP processes.

Skills

Leadership

Influencing

Agile delivery

GxP/GCP

Audit intelligence

Stakeholder management

Vendor management

Change leadership

Communication

Attention to detail

Education

Bachelor’s or equivalent degree

MS/PhD preferred in data science or related field

Job description

Johnson & Johnson is seeking an Associate Director, Quality Business Enablement to join the RDQ quality function. Located at multiple sites including Raritan, NJ and Titusville, NJ, the role partners with process owners to shape a portfolio of quality solutions that improve compliance and operational efficiency.

The role requires 10+ years in regulated industries, strong leadership, and deep GxP knowledge, with a track record in agile delivery, UAT, and adoption planning.