Associate Director, Quality Business Enablement

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

R&D/Scientific Quality

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, San Diego, California, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Associate Director, Quality Business Enablement to be located at Raritan, NJ; Titusville, NJ, Horsham, PA and/or San Diego, CA.

Purpose:

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.

You will be responsible for:

• Business Partnership & Solution Strategy: 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.

• Portfolio Leadership & Delivery Governance: 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.

• Strategy & Prioritization Influence: 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.

• Business Requirements & Value Realization: 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.

• Inspection Intelligence & Quality Innovation: 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.

• Compliance, Validation & Risk Management: 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.

• Enterprise Partnership & Technology Enablement: 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.

• Change Leadership & Capability Building: 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.

• Vendor & Resource Oversight: 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.

Additional Responsibilities:

• 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.

Qualifications / Requirements:

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.

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.

• 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.

Other:

• This position may require up to 10% domestic and international travel.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Onsite 

Required Skills:

Preferred 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, Standard Operating Procedure (SOP), Technical Credibility, Training People

The anticipated base pay range for this position is :

$137,000.00 - $235,750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits