Job Title
Associate Director, Preclinical Operations
Company
Johnson & Johnson
Location
Cincinnati, Ohio, United States
Fully onsite role
Job Function
Discovery & Pre-Clinical/Clinical Development
Job Sub-Function
Multi-Family Pre-Clinical Development – MedTech
Job Category
Senior Manager, Multi-Family Pre-Clinical Development – MedTech (PL8)
Requisition Number
R-026713
Date Posted
September 5, 2025
Application Deadline
September 26, 2025 (may be extended)
Company Overview
Johnson & Johnson is committed to healthcare innovation aimed at preventing, treating, and curing complex diseases with smarter, less invasive, and personalized solutions. Our combined expertise in Innovative Medicine and MedTech drives breakthrough health solutions that impact humanity.
Learn more: jnj.com
Role Purpose
The Associate Director, Preclinical Operations leads operations to support execution of preclinical studies that position Johnson & Johnson MedTech products competitively for regulatory approval and clinical adoption. This role manages resource acquisition, vendor management, quality metrics, and continuous improvement within the Preclinical Research department.
Key Responsibilities
Quality System Management
Develop and implement quality metrics to drive improvement initiatives.
Establish and maintain risk assessment processes for phase audits.
Oversee management of Preclinical Research archiving.
Training Management
Direct development of preclinical training curriculum.
Develop project planning templates and train staff.
Oversee document control management implementation.
Resourcing Management
Lead process improvement initiatives for operational efficiency.
Optimize resource models to drive effective utilization.
Develop and implement end-to-end project/program plans and timelines.
Manage external vendors (e.g., CROs), audit schedules, and vendor approval.
Partner with preclinical leaders to prioritize critical equipment acquisition and new model capabilities.
Develop tools to track deliverables, identify resource constraints, and evaluate performance.
Communicate business issues and opportunities to management.
Ensure compliance with health, safety, environmental, and regulatory guidelines.
Other Duties
Perform additional tasks as assigned to support department and business goals.
Education & Experience
Education
Master’s degree in Business Administration with specialization in Operations required.
Experience
Minimum 7 years managing operations in an industry setting.
Medical Device industry or medical field experience preferred.
Strong knowledge of preclinical practices and procedures.
Advanced understanding of 21 CFR Part 58 (GLP) and Part 820 (QSR) regulations.
Experience managing complex projects and driving continuous improvement.
Proven ability to communicate effectively with staff and leadership.
Experience managing both full-time and contract staff.
Demonstrated experience with Good Documentation Practices (GDP) for medical devices.
Experience in GLP study execution for regulatory submissions.
Deep understanding of GLP test article and archive management.
Strong background in quality system management and project management.
Travel
Up to 20% travel required
Equal Opportunity Statement
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other legally protected characteristics.
Accommodation Statement
Johnson & Johnson is committed to an inclusive interview process. Applicants with disabilities who require accommodations can contact the Employee Health Support Center at ra-employeehealthsup@its.jnj.com or AskGS.
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