Quality Systems Manager

Overview

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 Med Tech, 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

Quality

Quality Assurance

Professional

Wilson, North Carolina, United States of America

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

Johnson & Johnson is currently seeking a Quality Systems Manager to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina. This role will support the construction, operational start‑up and end state of the DS site operations located in Wilson NC. You will be required to be 5 days a week on the site in Wilson, NC.

Based on the current project stage, the travel requirements will be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

• Responsible for developing, implementing, and monitoring the effectiveness of all core Quality Systems in compliance with applicable regulations and industry standards (Nonconformance and CAPA, Change Control, Document Management, GMP training, quality agreements process, complaints system, and global J&J standard processes).
• Manage the development of a long‑term vision and strategy for these quality systems in close cooperation with site leadership and translate these strategies into compliant programs and processes in line with regulations and business expectations.
• Responsible for the site’s Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site.
• Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees.
• Provide guidance and support to departments on quality system‑related matters.
• Manage the resolution of unexpected complex compliance or quality system issues as they arise.
• Develop and deliver training programs to enhance employees’ understanding of quality systems and regulatory requirements.
• Keep abreast of regulatory changes and industry best practices related to quality systems and ensure timely implementation of necessary updates.
• Manage relationships with external regulatory agencies and auditors, supporting inspections and audits as required.
• Partner with peers and Quality Heads at other J&J sites to ensure harmonization and alignment with J&J Quality Policies, Guidelines, Programs and Systems.
• Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.
• Support the development of the Quality department budget in line with routine business planning cycles.

• Bachelor’s degree in a scientific or engineering discipline is required.
• A minimum of 6 years’ experience working within the biological and/or pharmaceutical industry.
• Strong knowledge of relevant regulations and…