Quality Solutions Lead — Strategy & Enablement

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

Benefits offered by this job

Vacation – 120 hours/year

Sick time – 40 hours/year (Colorado) /

Holiday pay including floating days –

Work, Personal and Family Time – up to

Parental Leave – 480 hours within one年

Bereavement Leave – 240 hours

Job summary

Johnson & Johnson is seeking an Associate Director, Quality Business Enablement to lead a portfolio of quality solutions within R&D Quality. Located at Raritan, NJ and/or Titusville, NJ or Horsham, PA, or San Diego, CA, this role bridges business and technology to deliver validated, compliant, and scalable quality systems.

You will drive strategy, prioritization, and adoption across audit readiness, inspection management, and analytics while ensuring GxP compliance and regulatory readiness.

Qualifications

• Education: A minimum of a Bachelor’s or equivalent University degree is required.
• MS/PhD preferred in data science, statistics, AI, computer science/engineering, life sciences or related fields.
• 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.
• Deep expertise in GxP/GCP requirements, GAMP 5, CSA/CSV, data integrity, audit trail, and 21 CFR Part 11 expectations.
• Working understanding of traditional and modern digital capabilities as well as quality‑related systems in a regulated environment.
• Demonstrated 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.
• Strong collaboration, alignment, change leadership, and influencing skills across a matrixed organization.
• A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.

Responsibilities

• Partner with process owners, functional leaders, and stakeholders to understand QA processes and identify improvement opportunities; align priorities into a portfolio of quality solutions.
• Provide program leadership and governance for quality solution initiatives, ensuring objectives, scope, resources, risks, timelines, validation expectations, and measures are aligned.
• Facilitate evaluation of opportunities, trade-offs, and business value to support prioritization and investment decisions.
• Drive definition of business outcomes, adoption expectations, ensuring requirements translate into scalable solutions delivering measurable value.
• Champion inspection intelligence, audit analytics, automation, and AI-enabled capabilities to strengthen readiness and proactive quality management.
• Ensure solutions comply with GxP/GCP, GAMP 5, CSA/CSV, data integrity, audit trail, 21 CFR Part 11; maintain documentation and lifecycle controls.
• Serve as RDQ’s liaison to Enterprise AI, Quality Data & Analytics, and Johnson & Johnson Technology; promote reuse of enterprise platforms and governance.
• Drive stakeholder engagement, training, and adoption; build sustainable capabilities and reduce dependency risk.
• Provide direction and oversight to internal, external, offshore resources; manage progress and accept deliverables.
• Communicate portfolio priorities, progress, risks, and adoption status to senior leadership; manage complex initiatives independently.
• Stay aware of regulatory and external AI governance for GxP decisions and advise on proofs of concept.

Skills

Agility Jumps

Collaboration

Compliance Management

Consulting

Continuous Improvement

Mentorship

Organizing

Product Strategies

Quality Control (QC)

Quality Control Testing

Quality Management Systems (QMS)

Quality Standards

Regulatory Environment

Researching

SOP

Technical Credibility

Training People

Education

Bachelor’s degree or equivalent

MS/PhD preferred in data science, statistics, AI, computer science/engineering, life sciences or related fields

Job description

Johnson & Johnson is seeking an Associate Director, Quality Business Enablement to lead a portfolio of quality solutions within R&D Quality. Located at Raritan, NJ and/or Titusville, NJ or Horsham, PA, or San Diego, CA, this role bridges business and technology to deliver validated, compliant, and scalable quality systems.

You will drive strategy, prioritization, and adoption across audit readiness, inspection management, and analytics while ensuring GxP compliance and regulatory readiness.