Manager, Clinical Quality Lead

$100,000 - $197,800/Yr

Johnson & Johnson - Irvine, CA

Full-time - Mid Level

Hybrid - Irvine, CA

Chemical Manufacturing

About the position

The Manager, Clinical Quality Lead at Johnson & Johnson is responsible for providing clinical quality oversight in support of the Laminar MedTech business. This role involves leading the implementation of a robust GxP Quality Management System, ensuring compliance with Good Clinical Practice (GCP) and other applicable regulations. The position requires collaboration across various functions to support new product development, integration of acquired assets, and risk management strategies, while also preparing for regulatory inspections and audits.

Responsibilities

• Lead clinical quality and integration activities for new product development and lifecycle management.
• Ensure compliance with GCP regulations and internal procedures.
• Support new business development initiatives, including due diligence and post-acquisition assessments.
• Develop proactive risk management strategies in coordination with Clinical R&D partners.
• Prepare and provide updates on the state of the Quality Management System (QMS).
• Conduct clinical audits and prepare for regulatory inspections.
• Collaborate with cross-functional teams to implement an effective GCP quality program.

Requirements

• Bachelor's degree in a scientific or business field.
• 6-8 years of clinical research or clinical quality experience in a life sciences organization.
• Strong knowledge of GCP, ISO 14155:2020, ICH-GCP, and relevant clinical research regulations.
• Demonstrated experience in leading cross-functional teams and establishing collaborative relationships.
• Excellent written and verbal communication skills in English.
• Strong project management and execution skills.

Nice-to-haves

• Experience in licensing, mergers, and acquisitions.
• Customer/external facing role experience.
• Health authority inspection experience.

Benefits

• Eligible for J&J Flex hybrid working model, working onsite at least three days per week.