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:

Johnson & Johnson is recruiting for a Head of Quality and Compliance (Q& C) Leader for our Ottava platform. This role will report to Global VP of Q& C Robotics and Digital and located in Santa Clara, California.

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Position Summary

This is an end-to-end role with current and future responsibilities including Design Controls, Manufacturing and Operations, Quality and Compliance and Post Market Surveillance.

Our Sr. Director, Quality & Compliance; Ottava Platform & Advanced Imaging role will drive exceptional product quality including focus on customer safety and design, manufacturability and reliability throughout the R& D/Product Development, Operations and Quality teams and into the product. 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. The leader will work with 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, project planning, and associated Quality Management System processes.

The Head of Ottava 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 and market releases. They will be responsible for leading and working with Ottava and Robotics 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 Ottava and manage and partner on key strategic initiatives/programs across Q& C and platforms to focus on continuous business growth and improvements. They will drive compliance and accountability for Quality Management Systems within Ottava Platform including successful execution of Internal/External Audit program in partnership with Medtech teams and business functions, manage audits/inspection outcomes with Notified Bodies and FDA, lead and drive effective oversight of CAPA Program and drive business accountability to various quality based KPIs. As part of continuous transformation, the leader will ensure Ottava Q& C teams remain focused to transforming 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; Ottava Platform & Advanced Imaging will:

• Act as a strategic thought partner with Ottava 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 the 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 championing initiatives across platform that incorporates risk management, process excellence and transformation activities to align business benefits with action and resource prioritization.
• Recruit and further develop highly competent Quality and Compliance professionals while focusing on technology-driven competencies, leadership-based behaviors with end-to-end accountability modeling.
• Develop and set strategic direction for quality and compliance that integrates customer, product and market requirements to meet the goals of the franchise.

Qualifications

• 20 + years in developing, implementing, and managing design and development, manufacturing, and quality management systems in regulated industry with at least 12 years in a medical device industry.
• Minimum 10 years as a quality leader including 4 or more yrs. as Director or above in a quality function across Design and Development and/or End-to-End Quality Leader role in Medical Device is required.
• Must have a minimum 5 years of Capital Medical Device Equipment experience as a quality leader with focus on design and development including software (embedded), and/or manufacturing, and post market surveillance, and servicing.
• Experience with design and development and/or manufacturing of Robotic Surgical Systems is desirable.
• Proven experience with the application of Design Controls, Statistical Methods, Quality Engineering and Management principles, and Risk Management with exposure to supply chain, operations, post market surveillance.
• Strong hands-on working knowledge of risk management and electrical safety standards including EN ISO 14971 and IEC 60601.
• Good expertise in various standards and regulations including but not limited to 21 CFR Part 820, EN ISO 13485, 21 CFR 803/810, IEC 62304, 21 CFR part 11 and good working knowledge of EUMDR/MDSAP, SOR/98-282, Health Canada, MHLW, TGA, and other international regulations.
• Must have demonstrated and implemented Quality Based transformation improvement programs including scalable and integrated quality management systems and shown strong capability to resolve quality and compliance remediation across quality management systems.
• Proven track record of leading and facilitating successful audits and inspections with regulatory bodies including FDA and various Foreign Government Health Authorities and Notified Bodies.
• Strong knowledge of and application to Product Human Factors, Usability Engineering and Product Reliability.
• Must have clearly demonstrated being an effective leader for people development and talent growth.
• Experience with SaMD, Robotics/AI, and optical/imaging devices and systems is desirable.

Key skill/leadership requirements:

• Influence management, collaboration, and leading cross-functional teams during complex capital medical device product reviews including building solutions and consensus to achieve risk-based outcomes.
• Analytical in solving problems and achieving quality and business objectives by demonstrating innovative approaches to Quality Engineering applications and efficiencies.
• Strategic leader and be able to deep dive into critical situations.
• Drive strategic and focused vision mindset in developing and projecting mid to long term functional strategies and transformational activities.
• Demonstrate experience in leading and developing individuals and teams and be proficient as a leading leader consistent with Johnson & Johnson’s Leadership Imperatives and Credo.

ROLE LOCATION: This role is located at our Santa Clara Robotics Campus, California and will be required to be on-site. The role includes responsibilities across multiple sites.

RELOCATION: Relocation will be provided to the right candidate.

SUPERVISORY RESPONSIBILITIES: Supervise Managers and individual contributors across multiple sites. Manage current organization in excess of 100 + individuals.

TRAVEL REQUIREMENTS: 20% plus travel may be required. From time-to-time business required travel may exceed > 20%.

The anticipated base pay range for this position is:

200, 000 - 343, 850

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits