Senior Business Analyst, R&D Quality
$109k - $174.8kJohnson & Johnson Innovative Medicine
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:
QualityJob Sub Function:
R&D/Scientific QualityJob Category:
ProfessionalAll Job Posting Locations:
Horsham, Pennsylvania, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of AmericaJob 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
We are searching for the best talent for Senior Business Analyst, R&D Quality to be located at Raritan, NJ; Titusville, NJ; Horsham, PA or La Jolla, CA.
Purpose:
The Senior Business Analyst, R&D Quality, is a member of the Quality Assurance (QA) function within R&D Quality (RDQ). The role partners with process owners and business stakeholders to understand business challenges, define requirements, prioritize opportunities, and translate business needs into analytics, reporting, automation, and quality solution deliverables that improve operational effectiveness, inspection readiness, compliance, and data-driven decision-making. Acting as a bridge between business and technology teams, this role supports recurring quality metrics, dashboards, inspection intelligence, data analysis, user adoption, and continuous improvement while enabling leadership to focus on innovation strategy, governance, and portfolio prioritization.
You will be responsible for:
Requirements & Stakeholder Liaison : Partner with metric and process owners to understand business challenges, define reporting and analytics requirements, agree metric definitions, data sources, calculation logic, output format, and business ownership before build. Triage incoming requests, identify opportunities to reuse or improve existing reporting, and translate business needs into actionable deliverables.
Quality Metrics & Reporting : Operate the monthly and quarterly metrics cycle, including extraction, validation, calculation, review, publication, and issue follow-up. Maintain documented, reproducible processes, standardized definitions, visual conventions and filter logic, and investigate anomalies with process owners before publication.
Inspection & Audit Intelligence : Serve as primary analyst for audit and inspection data, supporting inspection readiness through trend analysis, repeat-finding detection, proactive risk sensing, readiness gap analysis, and rapid evidence generation under time pressure.
Analytics, Data Engineering & Knowledge Continuity : Build and maintain dashboards, data pipelines, data models, reconciliations, data dictionaries, lineage documentation, and support processes using approved analytics tools such as SQL, Power BI, Tableau, or other approved platforms. Strengthen continuity by documenting logic, data sources, reporting standards, and support processes.
Innovation & Solution Evaluation : Evaluate emerging analytics, automation, and AI-enabled capabilities against real RDQ use cases, (e.g., M365 Copilot, Copilot Studio, Power Platform, RAG-based retrieval, agentic workflow support). Build or support proofs of concept that test feasibility, data readiness, compliance fit, and business value.
Technology Adoption & Enablement : Support adoption of delivered solutions by developing user guides and training, running office hours, providing hands-on user support, identifying process-owner champions, and monitoring usage so delivered capabilities convert into sustained business value.
Delivery & Vendor Coordination : Execute assigned backlog items, support solution delivery, prepare and execute UAT scripts, log defects, verify releases, and coordinate day-to-day with offshore and vendor developers. Clarify requirements, confirm quality and documentation expectations, and verify output before business acceptance.
Cross-Functional Collaboration : Partner with JJIM Quality Data & Analytics, R&D stakeholders, enterprise platform owners, and other beneficiaries across IM and MedTech to align on requirements, support solution delivery, and ensure RDQ business needs are represented in broader initiatives.
Prepare leadership-ready summaries, commentary, project decks and presentations that interpret results and create actionable insights addressing specific needs rather than solely present data.
Automate manual reporting and data preparation activity, retire reports no longer used, and track capacity returned to the business.
Apply data integrity, audit trail and 21 CFR Part 11 expectations to data handling and reporting outputs.
Manage multiple concurrent requests with a high level of independence to ensure timely and accurate completion of activities.
Qualifications / Requirements:
Education:
A minimum of a Bachelor’s or equivalent University degree is required.
Required:
A minimum of 4 years of work experience in data analytics, management, or similar.
Pharmaceutical, Biotechnology and/or Medical Device industry experience.
Experience gathering reporting requirements directly from business stakeholders and translating them into delivered reports.
Experience with data modeling and building or maintaining data pipelines.
Strong collaboration and influencing skills, with the ability to summarize and present results to senior audiences.
Preferred:
GxP or quality data exposure.
Hands-on experience building and operating dashboards in Power BI and/or Tableau.
Knowledge of GenAI/LLM, RAG, Copilot or AI-enabled solutions.
Hands-on proficiency with SQL and Python.
Working knowledge of GAMP 5 and CSA at execution level, Part 11, data integrity and audit trail review.
Experience coordinating with offshore or vendor development teams.
Other:
This position may require up to 5% domestic 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 , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Onsite
Required Skills:
Preferred Skills:
Business Data Analytics, Communication, Compliance Management, Continuous Improvement, Data Analytics, Data Savvy, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, ResearchingThe anticipated base pay range for this position is :
$109,000.00 - $174,800.00Additional 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: -- Tris Pharma, Inc. is seeking an experienced Senior or Executive Director of Research and Development Quality Assurance to lead our R&D QA programs in a hybrid NJ setting. This senior role partners with R&D, Regulatory, Medical Affairs, and Pharmacovigilance to ensure robust...QualitySenior
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