External Quality Advance Therapy Manager

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 .

We are searching for the best talent for External Quality Advance Therapy Manager to be in Sao Paulo, Brazil

You will be responsible for :


* Responsible for quality oversight and qualifying external apheresis and cell collection laboratories/cryopreservation facilities.


* Continuously supervise all aspects of site performance and provide direction to site leaders to ensure quality compliance with regulatory requirements.


* Coordinate and provide concurrences on deviations, change controls and CAPAs.

Develop, implement, and review SOPs for interactions with External Partners


* Provide leadership and insights as a member of global project team.

Monitor trends, identify issues, recommend, and implement appropriate actions


* Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship/collection sites


* Review relevant regulatory documents prior to submission


* Perform tasks in a manner consistent with the safety policies, quality systems and cGMP/GTP requirements under limited supervision


* Adaptable and flexible for other duties that may be assigned as needed



* Bachelor Degree in life science relatred areas, Pharmacist, nurse, doctors, Microbiologisy


* At least 7 years of experience in quality in general.


* Have experience in quality management system, supplier qualification, audit and monitoring, general quality elements, advanced therapies products, cell product (e.g.: NC/CAPA, change control, KPIs, document control, etc) customer relationship, Brazil HA regulations.


* 50% domestic travel
...