Clinical Product Release Lead

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:

Quality Control

Job Category:

Business Enablement/Support

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson Vision, a member of the Johnson & Johnson Family of Companies, is recruiting for a Clinical Product Release Lead, located in Jacksonville, Florida.

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This lead role is primarily responsible for all activities related to the review and release of products manufactured for clinical evaluation. They are the primary point of contact in coordinating release activities between project teams and the product release team to adhere to project schedule and timely release of clinical product that meets Research and Development (R&D) Quality Systems and study protocol requirements. This also includes the approval of R&D raw materials used to manufacture clinical products.

Key Responsibilities:

• Responsible for reviewing electronic and manual records related to device history, raw materials, and sterilization activities to ensure compliance with company policies and regulatory requirements prior to product release. Provide quality approval for Device History Records (DHRs) and clinical product documentation associated with new product introductions.
• Drive the resolution of nonconformances identified during DHR review by partnering with cross-functional personnel and project leaders. Lead R&D quality events, including investigations and corrective and preventive actions (CAPAs), to ensure timely completion, documentation, and regulatory compliance.
• Daily management of work-in-process to align product release priorities and goals with appropriate departments such as the R&D Pilot Line and clinical supply.
• Serve as a trainer and mentor for Product Release personnel and other functional areas by delivering instruction on quality processes, product release requirements, and compliance expectations.
• Serve as the Quality Systems subject matter expert for R&D quality processes and electronic quality systems during internal audits and regulatory inspections. Provide expert interpretation of procedures, quality records, training documentation, document control processes, and compliance requirements.
• Provide quality mentorship, risk-based decision-making, and quality systems expertise to support continuous improvement and process excellence initiatives that improve compliance, efficiency, and overall quality performance.

Qualifications

Education:

• Bachelor's or equivalent degree is required. Concentration in a technical or scientific field such as Quality, Life Sciences, Engineering, Chemistry, Biology, Regulatory Affairs, or a related field is preferred.

Experience and Skills:

Required:

• 6-8 years of work experience in a regulated healthcare, medical device, pharmaceutical, consumer products, distribution, commercial quality, or quality systems environment.
• Proven experience working within quality management systems (QMS) and/or regulated environments in compliance with applicable FDA regulations, ISO 13485, and ISO 9001 regulations and standards.
• Strong attention to detail and critical thinking skills required.
• Excellent problem resolution, organizational, team interaction, interpersonal, written and oral communication skills.
• Experience authoring, reviewing, or approving, quality system documentation, including procedures, work instructions, forms, and records.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
• This position supports records and document management activities that require the retrieval, movement, and storage of file boxes containing controlled documents and records weighing up to 22 pounds.

Preferred:

• Experience with Microsoft Power Platform (Power Apps, Power Automate, and Power BI).

Other:

• Up to 10 % 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:

Administrative Support, Communication, Compliance Management, Controls Compliance, Execution Focus, ISO 9001, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Report Writing, Standard Operating Procedure (SOP), Teamwork, Technologically Savvy