Preclinical Compliance Associate

Job description

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: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Biological Research Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America Job Description: Johnson & Johnson MedTech, Electrophysiology, is recruiting a Preclinical Compliance Associate This position is located in Irvine, CA and will be following a hybrid model. 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. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Purpose: The Preclinical Compliance and Planning Associate will drive contract-research lab strategies, ensure compliance with all internal and external animal welfare requirements, collaborate on strategic partnerships, manage project timelines, and oversee process improvements to improve the functioning of the Preclinical Research Department. You will be responsible for: Act as primary coordinator for CRO strategy and execution: evaluate when to outsource vs. perform work internally, select vendors, and manage study handoffs and timelines. Develop, review, and enforce Standard Operating Procedures (SOPs) Design, implement, and manage chemical, biological, and radiological safety programs, including CAPA (corrective and preventive action) processes. Manage preventive maintenance, calibration, and service schedules for critical equipment (e.g., biosafety cabinets, anesthesia systems, radiology devices). Identify, qualify, and onboard external laboratories and service providers using a structured supplier qualification process and required documentation. Manage outsourcing relationships and vendor communications to ensure deliverables meet scientific, quality, and compliance expectations. Serve as the lab scheduling and resource-allocation lead to optimize facility usage, reduce bottlenecks, and support project timelines. Coordinate procurement for lab usage and research materials: generate purchase requests, manage budgets, and track expenses with finance partners. Monitor and manage finance/budget aspects for preclinical operations, including forecasting, tracking spend vs. plan, and identifying cost-saving opportunities. Create and maintain job descriptions and role expectations for preclinical staff; support hiring and onboarding processes. Track and report key performance indicators (KPIs) and operational metrics (e.g., study throughput, animal census, equipment uptime, training compliance) to leadership. Maintain an annual calendar of important regulatory, accreditation, and operational milestones to ensure proactive planning and timely submissions. Manage documentation control, record retention, and data integrity practices to support audits and reproducible science. Drive continuous improvement initiatives across operations, quality, and compliance, and lead cross-functional corrective/preventive actions. Qualifications / Requirements: A minimum of a Bachelor’s Degree A minimum of 2 years of relevant experience is required Proven track record of contributing to medical programs on time, within budget and in compliance to SOPs and regulations is required. Up to 25% domestic and international travel may be required. 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. Required Skills: Preferred Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaboration, Communication, Critical Thinking, Data Analysis, Data Savvy, Digital Culture, Digital Literacy, Healthcare Trends, Medical Affairs, Medical Communications, Medical Compliance, Product Development Lifecycle, Report Writing, Stakeholder Engagement, Technologically Savvy The anticipated base pay range for this position is : $92,000.00 - $148,350.00 Additional Description for Pay Transparency: 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