Head of Quality & Compliance, Monarch Platform

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Job Summary:

Auris Health, a member of Johnson & Johnson's Family of Companies, is recruiting for Head of Quality and Compliance (Q&C) Leader for our Monarch platform.  This role will directly report to Global VP of Q&C Robotics and Digital Surgery and will be in Santa Clara, California. 

This role is an end-to-end role with responsibilities including Design & Development, Manufacturing/Operations, Quality & Compliance and Post Market Surveillance.

As a leader, you will drive exceptional Quality and Compliance including focus on customer safety and product design, and manufacturability and reliability throughout the Product Development, Operations, Distribution, and Commercial processes. The leader will have direct quality influence on components, assemblies, final products, suppliers, including R&D and production builds and product release for testing and commercialization. They will work with a team of quality associates, engineers and managers and will actively lead quality & compliance-based requirements for risk management, design concepts & specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, manufacturing, supplier controls, post market surveillance, project planning, and associated Quality Management System processes.

The Head of Monarch Q&C will partner closely with cross functional teams including but not limited to R&D, Supply Chain/Manufacturing, Clinical and Medical Affairs, Regulatory Affairs, Service, Marketing, in furthering new product development, manufacturing, delivery and market releases.  They will be responsible for leading and working with Monarch Quality & Compliance (Q&C) teams in continuously implementing and maintaining a compliant, scalable, agile and effective QMS.  They will actively work with Global VP Q&C Robotics to develop and shape the multi-year Q&C strategy applicable to Monarch and RAD and manage and partner on key strategic initiatives/programs across Q&C and platforms to focus on continuous business growth and improvements. The leader will drive compliance and accountability for Quality Management Systems within Monarch Platform including successful execution of Internal/External Audit program in partnership with RAD/Medtech teams and business functions, manage audit/inspection outcomes with Notified Bodies and FDA, lead and drive effective oversight of CAPA Program and drive accountability to various quality based KPIs.  As part of continuous transformation, the leader will ensure Monarch Q&C teams remain focused on transforming RAD based QMS processes to Fit for Purpose and scale up business needs by delivering on next phase on effective, reliable, agile, compliant and scalable QMS.

Sr. Director, Quality & Compliance; Monarch Platform will:

• Act as a strategic thought partner with Monarch platform business leaders in the development of the business strategy and will effectively link the Quality objectives to the business strategy.
• Focus on implementation of policies and strategies for Quality Management Systems to ensure compliance with regulations and industry standards including customer safety and satisfaction and regulatory compliance with business objectives.
• Prioritize and resource benchmarking activities and participate in best business practice sharing internally across Johnson & Johnson and externally to drive competitive advantage.
• Demonstrate an ability to understand current and emerging regulations and approaches for clinical research involving clinical trials and existing requirements for sponsors of clinical investigations involving medical devices.
• Partner with Operations and Process Excellence to set strategies that drive continuous improvements for the customer and cha