Quality Director

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

Job Function:

Quality

Job Sub Function:

Multi-Family Quality

Job Category:

People Leader

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

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

We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site.

For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to 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.

This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations. These functions and activities include Quality Control testing, Quality Assurance review and approval functions, Compliance activities, Product Release activities, etc. This role has the authority to make decisions in the following areas:

* Disposition of all incoming materials (incoming drug substance, excipients, components, packaging materials, etc.) and materials manufactured in the facilities at the site.

* Decisions with respect to Quality and Compliance.

* Reporting the Performance of the Quality System.

The initial 5 years of this role will predominantly focus on leading/directing all Quality aspects in completing the conceptual design, basis of design, detailed design, construction, commissioning/qualification, process validation, and regulatory submission/approval for this new U.S.

-based Biotherapeutic manufacturing facility.

Key Responsibilities:

* Provide overall Quality leadership and guidance to all site functional areas and management teams to ensure that business goals are achieved in compliance with all regulations and with a high level of quality meeting Johnson & Johnson's Quality Policy Standards.

* Develop and champion a Quality culture that promotes behaviors that lead to superior business performance and organizational excellence.

* Partner with peers in equivalent roles at other Innovative Medicine Supply Chain Sites to ensure harmonization and alignment with Innovative Medicine Supply Chain Quality Policies, Guidelines, Programs and Systems.

* Responsible for appropriately staffing and developing the Quality organization to meet business needs and succession plans. This includes mentoring and coaching staff as well as developing and implementing training…