Manager, Quality Assurance (QA) Preclinical Auditor

Company: Disability Solutions
Location: Cincinnati
Posted on: October 23, 2024

Job Description:

Johnson & Johnson MedTech is recruiting a Manager, Quality Assurance (QA) Preclinical Auditor to be located in Santa Clara, California or Cincinnati, Ohio.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.At Johnson & Johnson MedTech, we are working to solve the world's most pressing healthcare challenges through innovations at the intersection of biology and technology. We harness our deep expertise in surgery, orthopedics, vision, and interventional solutions to design healthcare solutions that are smarter, less invasive, and more personalized. The MedTech Surgery organization was recently established to combine Ethicon's market-leading surgical portfolio with the Robotics & Digital Solutions portfolio. The MedTech Surgical organization is comprised of: Wound Closure & Healing and Biosurgery, Endo Mechanical and Energy, OTTAVA (Surgical Robotics), MONARCH (Flexible Robotics), and MedTech Digital.Our Manager, QA Preclinical auditor is responsible for applying the Good Laboratory Practice regulations to help the company achieve two major objectives in support of the J&J Credo: Meet and exceed the expectations of our customers; and achieve and maintain compliance with regulatory expectations. To support business objectives, a successful Manager, QA Preclinical Auditor will have orientation to the big picture and attention to detail. Are you interested in joining a team that is developing the next generation of innovative devices that serve our surgeons and patients? Apply today!Key Responsibilities:

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• The Manager of Preclinical Quality Assurance will independently lead the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory GxP requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a support or lead role.
• Support other auditors in planning, conducting and reporting of audits.
• Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Support the CAPA process following the audit as needed.
• Encourage and support others to properly manage and document the risk-based approach in audit planning and conduct.
• Participate in regulatory inspections in a leadership role (e.g. host, backroom lead).
• Identify training needs, support development and provide training. Independently advise and coach other auditors.
• Supervise junior auditors / contractors and peer review audit reports.
• Lead initiatives and actively participate in key projects across the organization or company. Effectively influence key business partners to drive projects to completion.
• Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.
• Independently provide consultation and advice to business partners on quality and compliance processes / procedures.
• Interpret and apply regulations / policies to unique and / or complex issues.\r\r

Keywords: Disability Solutions, Fairfield , Manager, Quality Assurance (QA) Preclinical Auditor, Executive , Cincinnati, Ohio