Associate Director, Quality Business Enablement

Johnson & Johnson Innovative Medicine • Horsham, PA

7d • $137,000 - $235,750 • Hybrid

About The Position

The Associate Director, Quality Business Solutions is a member of the Quality Assurance (QA) function within R&D Quality (RDQ), responsible for partnering with process owners and business leaders to identify priorities, shape the quality solutions portfolio, and lead the delivery, adoption, and governance of business solutions that improve operational effectiveness, strengthen inspection readiness, and sustain GxP compliance. Acting as a bridge between business and technology organizations, the role ensures RDQ strategy is appropriately translated into operational and digital solutions which deliver measurable business value and scalable outcomes.

Requirements

• A minimum of a Bachelor’s or equivalent University degree is required.
• 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.
• 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.

Nice To Haves

• MS/PhD preferred in data science, statistics, AI, computer science/engineering, life sciences or related fields.
• Experience directing vendor or offshore delivery teams preferred.

Responsibilities

• Partner with process owners, functional leaders, and key stakeholders to understand how audit, inspection management, and quality systems processes are performed today; identify improvement opportunities; and align priorities into a cohesive portfolio of solutions that support RDQ strategic objectives, operational excellence, and compliance outcomes.
• Provide program leadership and governance for quality solution initiatives, ensuring business objectives, scope, resources, risks, timelines, validation expectations, and outcome measures remain aligned throughout the solution lifecycle.
• Facilitate evaluation of opportunities, trade-offs, and business value to support informed prioritization and investment decisions. Influence alignment across competing requests using consistent criteria such as operational efficiency, risk mitigation, compliance exposure, reuse potential, value realization, and portfolio sustainability.
• Drive definition of business outcomes, success measures, and adoption expectations, ensuring requirements are translated into scalable solutions by delivery teams and that implemented solutions deliver measurable value through efficiency gains, risk reduction, process improvement, or strengthened inspection readiness.
• Champion inspection intelligence, audit analytics, automation, and AI-enabled capabilities that strengthen inspection readiness, improve decision-making, and advance proactive quality management across RDQ and future cross-GxP use cases.
• Ensure solutions are developed, implemented, and maintained in accordance with GxP/GCP, GAMP 5, CSA/CSV, data integrity, audit trail, 21 CFR Part 11, responsible AI, privacy, security, and applicable governance expectations, maintaining inspection-ready documentation and sustainable lifecycle controls.
• Serve as RDQ’s primary liaison to Enterprise AI, JJIM Quality Data & Analytics, and Johnson & Johnson Technology, ensuring RDQ business requirements are represented in enterprise initiatives and that solutions reuse enterprise platforms, standards, and governance frameworks rather than creating parallel capability.
• Drive stakeholder engagement, communication, training, organizational readiness, and adoption activities to ensure successful implementation and long-term sustainability of quality solutions. Build sustainable business capabilities, strengthen knowledge sharing, and reduce operational dependency risk.
• Provide direction and oversight to internal, external, offshore, and technology delivery resources, establishing priorities, monitoring progress, reviewing deliverables, and ensuring outputs meet quality, compliance, documentation, and business expectations before acceptance.
• Communicate portfolio priorities, progress, risks, decisions needed, realized value, and adoption status to senior leadership on a defined cadence.
• Interpret ambiguous business problems, create proposals, and implement solutions that address gaps and areas of potential improvement.
• Manage complex initiatives with a high level of independence to ensure timely and accurate completion of activities.
• Maintain awareness of the evolving regulatory and external landscape for AI-enabled decision-making in GxP processes and advise which proofs of concept warrant investment, adaptation, or progression to validated production.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level