Director, PV Quality Management

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is recruiting for a Director, PV Quality Management located in Titusville, NJ, Raritan, NJ, Beerse, Belgium, High Wycombe, UK, Maidenhead, UK, Allschwil, Switzerland or Schaffhausen, Switzerland.

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 https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• Belgium - Requisition Number: R-075920
• UK - Requisition Number: R-075915
• Switzerland - Requisition Number: 075918

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Innovative Medicine Quality Systems (IMQS) is responsible for the Innovative Medicine Quality Management Systems (QMS) and GxP Process Ownership, and is the Global Process Owner for Quality Management Processes. IMQS ensures foundational governance through quality performance management, and alignment with regulatory requirements and emerging industry expectations. The IMQS-Process and Data Management (PDM) team, part of the IMQS organization, specifically focuses on and partners with the R&D and Pharmacovigilance and intensively collaborates with key partners including R&D Quality, Johnson & Johnson Enterprise Innovation (JJEI), the Therapeutic Areas (TA), Global Development (GD), Global Regulatory Affairs (GRA), and the Global Medical Organization (OCMO/GMS) along the development process, from discovery, pre-clinical, clinical, launch to post-approval activities. The IMQS-PDM team is responsible for GxP Quality Management System, GxP Personnel Qualification and Training by providing compliant, easy accessible process content, and for making learning tailored to the moment-of-need and at the point-of-use.

As Director, Pharmacovigilance Quality Management, you lead a global team of PV Quality Management experts (PVQM experts) overseeing the end-to-end delivery of process, qualification and training in the IMQS supported QMS framework. You enable dedicated Business Partners to conduct R&D/Medical Safety in an efficient and compliant way, resulting in programs that allow for seamless registration of the J&J innovative products. You set the vision and strategy for process and personnel qualification management in collaboration with senior leaders in R&D functions.

You are the single point of contact for senior management with business partners where you are responsible for roll out and training of the overall applicable quality framework. As an owner of the E2E procedural framework you are responsible for overall development of the PVQM strategy and ensuring Quality-by-Design principles are instigated in all PVQM deliverables. You are a member of the IMQS-PDM LT and collaborate with the other PDM Leads, the PDM Head and other positions in R&D to ensure an efficient and compliant QMS is deliver