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:** Supplier Quality **Job Category:** People Leader **All Job Posting Locations:** US052 OH Cincinnati - 4545 Creek Rd, US328 CA Santa Clara - 5490 Great America Pkwy **Job Description:** Johnson & Johnson is currently recruiting a Senior Manager Supplier Quality to join our Ottava organization in the Auris Health organization located in Santa Clara, CA, with additional consideration for candidates in Cincinnati, OH **.** 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/. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. The Senior Manager Supplier Quality is responsible for the quality aspects of OTTAVA suppliers and/or external manufacturers. This includes responsibility for developing, implementing, and maintaining company Purchasing Control processes and procedures for internally utilized suppliers and/or external manufacturing operations. The role is responsible for managing supplier related systems which include but not limited to change control, NC/CAPA, Quality Agreements, and specification development. The leader will drive the identification and mitigation of key supply chain issues/risks (supplier related) to improve and increase supplier reliability & performance. In addition, they will lead, develop and grow a high performing team of Supplier Quality Engineers. **Job** **Responsibilities:** + Manages performance and partners with supplier and/or external manufacturers to address challenges and execute improvement plans. + Provides guidance and support to project teams and affiliates regarding outsourced activities. Influencing business partners/project teams to continuously comply with purchasing procedures. + Partners with other members of the supply chain organization to promote new product introductions and ensure continuity between R&D and commercial supplier and/or external manufacturing projects. + Leads supplier selection and supplier qualifications activities, ensuring suppliers/external operations meet RAD OTTAVA quality and regulatory requirements. + Work closely with their team to build their talent profile and focus on building and maintaining an effective and accountable team that is considered best in class. + Tracks and trends key quality indicators/metrics to monitor supplier and QMS performance. + Responsible for quality technical assessments, quality agreements, supplier change control, supplier non-conformance, and CAPA related activities. + Partners with internal customers (Sourcing, Planning, QA, Operations, R&D, Regulatory, Distribution, Marketing, etc.) and suppliers and/or external manufacturers to ensure compliance to product requirements, material/component specifications, company procedures, FDA, ISO, etc. + Conducts supplier qualification activities at existing and prospective supplier and/or external manufacturers as needed. + Defines quality requirements for supplier and/or external manufacturing activities (i.e., material, products, equipment, services, sterilization, etc.). + Lead/support internal and/or external regulatory inspection related activities in relation to all things supplier related. + Accountable, as applicable for compliance in accordance with regulations such as and from, but not limited to, FDA QSR, ISO 13485, EU MD Directive/Regulations, FDA 21 CFR 820, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for the company’s products including medical devices. + Lead/support decisions that are aligned with management objectives regarding work processes, plans, and schedules to achieve department objectives. + Responsible for communicating business related issues or opportunities to next management level. + Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans and responsible for communicating business related issues or opportunities to next management level. **Qualifications Education:** + A minimum of a bachelor’s degree in engineering or science discipline is required. **Required:** + A minimum of 10 years of related experience with at least 4 years minimum of people management experience in medical device. + Minimum 2 years of experience working within large capital equipment medical device manufacturers including embedded/standalone product related software. + Experience working within GXP environment and with international standards/requirements including but not limited to: EN/ISO 13485, 21 CFR Part 820/11, ISO 14971, IEC 60601, EUMDR, Canadian Medical Device Regulations (SOR/98-282), and other necessary medical device regulations and standards appropriate for this role. + Minimum 2 years' experience working directly with contract manufacturers within U.S. and/or global environment including developing and furthering product design requirements, supporting end to end manufacturing processes, and furthering quality management and compliance processes including supporting contract manufacturers with developing key quality management systems. + Demonstrated knowledge of manufacturing principles and practices, and procedures. + Component Qualification/Process Validation experience. + New production introduction + Consistent track record on continuous improvement initiatives and improvement methodologies. + Prior manufacturing, plant, or technical background. + Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls. + Demonstrated ability to identify compliance risks and assess business impact. + Ability to deal with complex issues using deductive reason, critical analysis skills and systematic approaches. + Ability to manage complexity and lead a diverse team is essential. **Preferred:** + Advanced degree. + Prior experience with FDA and/or Notified Body inspections. + Direct experience in plan and/or supplier GMP audits. + Track record with supporting intercompany and/or working closely with external suppliers, on major compliance initiatives including but not limited to quality management systems remediation and resolution with warning letter. + Green Belt or higher rank and/or Certified Lead Auditor (ISO 13485). + Displayed strong and balanced influence management skills to ensure implementation of strategic processes and improvements to quality management systems. + Prior experience in quality systems remediation including responses to regulators and has shown strong leadership in guiding multiple functions in driving effective root cause analysis. + Function as mentor in people development and ensure collaborating closely with their team to build and maintain talent development plans. + A leader with high integrity and trust, willing to negotiate for right solution, providing empowerment to their teams, is effective in managing conflicts, communicates with confidence, drives decision-making based on data and as appropriate balanced risk, and is adaptive to changes. + Build interdependent partnerships, and internal and external relationships. + Strong management skills. **Other** + This position may require up to 30% of domestic and/or international travel. **The anticipated base pay range for this position is :** Santa Clara: $138,000-$238,050, Cincinnati: $120,000-$207,000 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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.