Clinical Product Release Lead

Johnson & Johnson Innovative Medicine • Jacksonville, FL

6d • Onsite

About The Position

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

Requirements

• 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.

Nice To Haves

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

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level